Medicare Advantage

Cryosurgical Ablation of the Prostate Gland
MA11.022a

Policy

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 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

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
T2B
T2C
Greater than 1/2 of one lobe
Tumors involve both lobes
T3
T3A
T3B
Cancer extending beyond the prostate capsule
Tumor extends outside of the prostate, but not the seminal vesicles
Tumor has spread to the seminal vesicles


GLEASON SCORE

The Gleason Score is a grading system for prostate cancer tissue. This score is determined by characterizing the prostate cancer cells on a grade scale of 1 (most differentiated) to 5 (least differentiated) based on its appearance under a microscope. The two most prevalent grades are added up to equal the Gleason score. Generally, prostate cancer with a Gleason score 2-4 is considered well-differentiated or low grade; Gleason score 5-7 is considered moderately differentiated; Gleason score 8-10 is considered poorly differentiated or high-grade.

GRADE GROUP

A revised grading system for prostate cancer tissue was created at the 2014 International Society of Urological Pathology Consensus Conference, which further assigns Grade Groups, derived from the Gleason Score.

Grade Group​
Gleason Score
Gleason Pattern
1
 6
 3 + 3
2
7
3 + 4
3
7
4 + 3
4
8
4 + 4, 3 + 5, 5 + 3
5
9 or 10
4 + 5, 5 + 4, 5 + 5


This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, cryosurgery of the prostate is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this 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 individuals with high-risk localized prostate cancer is not recommended outside of a clinical trial.

For whole gland cryoablation as initial treatment for localized prostate cancer, the evidence includes several systematic reviews, two randomized controlled trials, and many comparative and noncomparative observational studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, functional outcomes, quality of life, and treatment-related morbidity. High-quality data comparing cryoablation with external-beam radiotherapy, radical prostatectomy, or active surveillance are lacking, but available data have suggested similar overall survival and disease-specific survival rates compared with radical prostatectomy and external-beam radiotherapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.


For whole gland cryoablation as salvage treatment for a recurrence of localized prostate cancer following radiotherapy, the evidence includes primarily noncomparative case series and a few retrospective studies comparing salvage cryoablation with salvage prostatectomy. Relevant outcomes are overall survival, disease-specific survival, symptoms, functional outcomes, quality of life, and treatment-related morbidity. High-quality data comparing cryoablation with prostatectomy was mixed, and evidence comparing cryotherapy with brachytherapy is lacking. Individuals in this group have few options and prostatectomy can be difficult in tissue that has been irradiated. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.​



References


American Cancer Society. Prostate Cancer. [ACS Web site]. 08/01/2019. Available at: http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-staging. Accessed April 19, 2021.

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 April 19, 2021.

Aus G. Cryosurgery for prostate cancer. J Urol.2008; 180(5):1882-1883.

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$230.9*3a$1*3a$Cryosurgery+of+Prostate&bc=gAAAACAAAAAAAA==&. Accessed April 19, 2021.

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Cryosurgical Salvage Therapy for Recurrent Prostate Cancer (CAG-00064N). [CMS web site]. 12/05/2000. Available at: Decision Memo for Cryosurgical Salvage Therapy for Recurrent Prostate Cancer (CAG-00064N) (cms.gov)​. Accessed April 19, 2021. 

Centers for Medicare & Medicaid Services (CMS). Decision Memo for CRYOSURGERY Ablation for Prostate Cancer (CAG-00031N). [CMS Web site]. 02/01/1999. Available at: Decision Memo for Cryosurgery Ablation for Prostate Cancer (CAG-00031N) (cms.gov)​. Accessed April 19, 2021.​

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. 

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. [EAU Web site]. 2021. Available at: https://uroweb.org/guideline/prostate-cancer/Accessed April 19, 2021.

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):760-764.

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):1089-1094.

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

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]. 02/12/2021.​​ Available at: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/HealthProfessional/page1/AllPagesAccessed April 19, 2021.

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):1625-1630.

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):905-915.

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):405-410.

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

CPT Procedure Code Number(s)
55873

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)

THE FOLLOWING CODE REPRESENTS PRIMARY TREATMENT OF PROSTATE CANCER:
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

4/7/2015
4/7/2015
5/19/2021
MA11.022
Medical Policy Bulletin
Medicare Advantage
No