Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Cryosurgical Ablation of the Prostate Gland

Policy #:11.11.03d

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.

MEDICALLY NECESSARY

Cryosurgical ablation of the prostate gland is considered medically necessary and, therefore, covered for either of the following:
  • As primary treatment for individuals with localized prostate cancer, stages T1--T3
  • As salvage therapy for recurrent prostate cancer for individuals with localized disease, when both of the following criteria are met:
    • Primary treatment with a trial of radiation therapy has failed
    • The individual's test results are consistent with at least one of the following:
      • Stage T2B or below
      • Gleason score less than 9
      • Prostate-specific antigen (PSA) less than 8 ng/mL

EXPERIMENTAL INVESTIGATIONAL

Subtotal prostate cryoablation is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service 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 health care professional'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

Transrectal ultrasonic guidance is utilized to monitor the freezing process during cryosurgical ablation of the prostate gland. This service is a component of the cryosurgical ablation procedure and is not eligible for separate reimbursement.

Multiple components of the equipment required to perform cryosurgical ablation of the prostate gland (e.g., cryoprobes, ultrasonic devices, warming devices) have received approval for use by the US Food and Drug Administration (FDA).

The following list classifies stages of prostate cancer (T1--T3) based on physical examination, pathology, laboratory, or radiology results:

T1Digitally unrecognized tumor
T1ALess than 5 percent of the transurethral resection of the prostate
(TURP) specimen, or low-to-medium grade tumor
T1BGreater than 5 percent of the TURP specimen, or high-grade tumor
T1CTumor detected by elevated prostate-specific antigen (PSA)
T2Digitally palpable tumor confined to the prostate
T2ALess than 1/2 of one lobe
T2BGreater than 1/2 of one lobe
T2CTumors involve both lobes
T3Cancer extending beyond the prostate capsule
T3ATumor extends outside of the prostate, but not the seminal vesicles
T3BTumor has spread to the seminal vesicles

BENEFIT APPLICATION

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

Description

The prostate is a gland located around the urinary outlet of the bladder in the male body. About the size of a chestnut, the prostate is composed of two side-by-side lobes connected in the front by a narrowed part of the gland and from behind by a middle lobe that lies above and between the ejaculatory ducts. The gland secretes a milky fluid that is discharged by excretory ducts into the prostatic urethra at the time of emission of semen.

Cryosurgical ablation of the prostate (CSAP), also known as cryosurgery of the prostate gland, reduces the size of the prostate gland by using extremely cold temperatures to destroy abnormal prostate tissue. Cryosurgical ablation of the prostate is performed by inserting a probe through an opening in the perineum to apply a freezing agent, such as liquid nitrogen, to the prostate gland and the probe is guided by transrectal ultrasonography.

The procedure modality involves either complete ablation of the prostate or focal ablation (subtotal cryoablation) only targeting diseased tissue while leaving normal tissue intact. In 2017, the American Urological Association, along with the American Society for Radiation Oncology and the Society for Urologic Oncology updated their joint guidelines on the management of clinically localized prostate cancer which included recommendations on focal treatment for low-risk and intermediate risk prostate cancer patients stating that focal therapy is not a standard care option because comparative outcome evidence is lacking. In addition, focal therapy for men with high-risk localized prostate cancer is not recommended outside of a clinical trial.

In 2001, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination (NCD) indicating that CSAP was medically necessary and appropriate as a primary treatment for patients with clinically localized prostate cancer, Stages T1--T3. Additionally, salvage CSAP for recurrent cancer was deemed medically necessary and appropriate only for patients with localized disease who have failed a trial of radiation therapy as their primary treatment and have either of the following conditions: Stage T2B or below, a Gleason score less than 9, or a Prostate-specific antigen (PSA) less than 8 ng/mL.
References


American Cancer Society. Prostate Cancer. [ACS Web site]. 03/11/2013. Available at: http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-staging. Accessed September 14, 2018.

American Urolgical Association (AUA). Clinically localized prostate cancer: AUA/ASTRO/SUO Guideline. [AUA Web site]. 2017. Available at: https://www.auanet.org/guidelines/prostate-cancer-clinically-localized-(2017). Accessed September 14, 2018.

Aus G. Cryosurgery for prostate cancer. J Urol.2008; 180(5):1882-3.

Bahn DK, Lee F, Badalament R, et al. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology. 2002;60(2 Suppl 1):3-11.

Ball AJ, Gambill B, Fabrizio MD, et al. Prospective longitudinal comparative study of early health-related quality-of-life outcomes in patients undergoing surgical treatment for localized prostate cancer: a short-term evaluation of five approaches from a single institution. J Endourol. 2006;20(10):723-731.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Cryoablation for the primary treatment of clinically localized prostate cancer. TEC Assessments. 2001;Volume16:Tab 6.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 230.9: Cryosurgery of prostate. [CMS Web site]. 07/01/01. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=123&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=cryosurgery&KeyWordLookUp=Title&KeyWordSearchType=And&ncd_id=230.9&ncd_version=1&basket=ncd*3a%24230.9*3a%241*3a%24Cryosurgery+of+Prostate&bc=gAAAACAAAAAAAA%3d%3d&. Accessed September 14, 2018.

Chin JL, Al-Zahrani AA, Autran-Gomez AM, et al. Extended followup oncologic outcome of randomized trial between cryoablation and external beam therapy for locally advanced prostate cancer (T2c-T3b). J Urol. 2012;188(4):1170-1175.

Chin JL, Ng CK, Touma NJ, et al. Randomized trial comparing cryoablation and external beam radiotherapy for T2C-T3B prostate cancer. Prostate Cancer Prostatic Dis. 2008;11(1):40-45.

Chin JL, Pautler SE, Mouraviev V, et al. Results of salvage cryoablation of the prostate after radiation: identifying predictors of treatment failure and complications. J Urol. 2001;165(6 Pt 1):1937-1941; discussion 1941-1932.

Chou R, Dana T, Bougatsos C, et al. Treatments for Localized Prostate Cancer: Systematic Review to Update the 2002 U.S. Preventive Services Task Force Recommendation (Report No. 12-05161-EF-1). Rockville (MD): Agency for Healthcare Research and Quality; 2011.

Cohen JK. Cryosurgery of the prostate: techniques and indications. Rev Urol. 2004;6(Suppl 4):S20-S26. Also available on the PubMed Central Web site at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1472869. Accessed June 08, 2016.

De La Taille A, Benson MC, Bagiella E, et al. Cryoablation for clinically localized prostate cancer using an argon-based system: complication rates and biochemical recurrence. BJU Int. 2000;85(3):281-286.

Donnelly BJ, Saliken JC, Brasher PM, et al. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer. 2010;116(2):323-330.

Elkjaer MC, Borre M. Oncological outcome after primary prostate cryoablation compared with radical prostatectomy: a single-centre experience. Scand J Urol. 2014;48(1):27-33.

Ellis DS. Cryosurgery as primary treatment for localized prostate cancer: a community hospital experience. Urology. 2002; 60(2 Suppl 1):34-9.

European Association of Urology (EAU). EAU-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer. 2017. Available at: https://uroweb.org/wp-content/uploads/09-Prostate-Cancer_2017_web.pdf. Accessed September 14, 2018.

Gao L, Yang L, Qian S, et al. Cryosurgery would be an effective option for clinically localized prostate cancer: a meta-analysis and systematic review. Sci Rep. 2016;6:27490.

Gould RS. Total cryosurgery of the prostate versus standard cryosurgery versus radical prostatectomy: comparison of early results and the role of transurethral resection in cryosurgery. J Urol. 1999;162(5):1653-1657.

Grimm P, Billiet I, Bostwick D, et al. Comparative analysis of prostate-specific antigen free survival outcomes for patients with low, intermediate and high risk prostate cancer treatment by radical therapy. Results from the Prostate Cancer Results Study Group. BJU Int. 2012;109 Suppl 1:22-29.

Han KR, Cohen JK, Miller RJ, et al. Treatment of organ confined prostate cancer with third generation cryosurgery: preliminary multicenter experience. J Urol. 2003;170(4 Pt 1):1126-1130.

Hubosky SG, Fabrizio MD, Schellhammer PF, et al. Single center experience with third-generation cryosurgery for management of organ-confined prostate cancer: critical evaluation of short-term outcomes, complications, and patient quality of life. J Endourol. 2007;21(12):1521-1531.

Ismail M, Ahmed S, Kastner C, et al. Salvage cryotherapy for recurrent prostate cancer after radiation failure: a prospective case series of the first 100 patients. BJU Int. 2007; 100(4):760-4.

Jones JS, Rewcastle JC, Donnelly BJ, et al. Whole gland primary prostate cryoablation: initial results from the cryo on-line data registry. J Urol. 2008;180(2):554-558.

Lian H, Guo H, Gan W, et al. Cryosurgery as primary treatment for localized prostate cancer. Int Urol Nephrol. 2011; 43(4):1089-94.

Mouraviev V, Spiess PE, Jones JS. Salvage cryoablation for locally recurrent prostate cancer following primary radiotherapy. Eur Urol. 2012;61(6):1204-11.

Long JP, Bahn D, Lee F, et al. Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology. 2001; 57(3):518-23.

Mouraviev V, Spiess PE, Jones JS. Salvage cryoablation for locally recurrent prostate cancer following primary radiotherapy. Eur Urol. Jun 2012;61(6):1204-1211.

National Cancer Institute. Prostate Cancer Treatment (PDQ). [NCI Web site]. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/HealthProfessional/page1/AllPages. Accessed September 14, 2018.

Ng CK, Moussa M, Downey DB, et al. Salvage cryoablation of the prostate: followup and analysis of predictive factors for outcome. J Urol. 2007;178(4 Pt 1):1253-7; discussion 57.

Onik G. Image-guided prostate cryosurgery: state of the art. Cancer Control. 2001;8(6):522-531.

Prepelica KL, Okeke Z, Murphy A, et al. Cryosurgical ablation of the prostate: high risk patient outcomes. Cancer. 2005; 103(8):1625-30.

Punnen S, Cooperberg MR, D'Amico AV et al. Management of biochemical recurrence after primary treatment of prostate cancer: a systematic review of the literature. Eur Urol. 2013; 64(6):905-15.

Ramsay CR, Adewuyi TE, Gray J, et al. Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation. Health Technol Assess. 2015;19(49):1-490.

Robinson JW, Donnelly BJ, Coupland K, et al. Quality of life 2 years after salvage cryosurgery for the treatment of local recurrence of prostate cancer after radiotherapy. Urol Oncol. 2006;24(6):472-486.

Robinson JW, Donnelly BJ, Siever JE, et al. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer: quality of life outcomes. Cancer. 2009; 115(20):4695-704.

Shelley M, Wilt TJ, Coles B, et al. Cryotherapy for localised prostate cancer. Cochrane Database Syst Rev. 2007(3):CD005010.

Tay KJ, Polascik TJ, Elshafei A, et al. Primary cryotherapy for high-grade clinically localized prostate cancer: oncologic and functional outcomes from the COLD Registry. J Endourol. 2016;30(1):43-48.

Wenske S, Quarrier S, Katz AE. Salvage cryosurgery of the prostate for failure after primary radiotherapy or cryosurgery: long-term clinical, functional, and oncologic outcomes in a large cohort at a tertiary referral centre. Eur Urol. 2013;64(1):1-7.

Williams SB, Lei Y, Nguyen PL, et al. Comparative effectiveness of cryotherapy vs brachytherapy for localised prostate cancer. BJU Int. 2012;110(2 Pt 2):E92-98.

Williams AK, Martinez CH, Lu C, et al. Disease-free survival following salvage cryotherapy for biopsy-proven radio-recurrent prostate cancer. Eur Urol. 2011; 60(3):405-10.

Wilt TJ, Shamliyan T, Taylor B, et al. Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer (Report No. 08-EHC010-EF). Rockville (MD): Agency for Healthcare Research and Quality; 2008.

Xiong T, Turner RM, Wei Y, et al. Comparative efficacy and safety of treatments for localised prostate cancer: an application of network meta-analysis. BMJ Open. 2014;4(5):e004285.





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)

55873


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


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

11.11.03d
10/24/2018This policy became effective 04/08/2015. It has been reviewed and reissued to communicate the Company’s continuing position on Cryosurgical Ablation of the Prostate Gland.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 04/08/2015
Version Issued Date: 04/08/2015
Version Reissued Date: 10/24/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.