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Date Printed: August 18, 2017: 10:19 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-54000-14

Original Effective Date: 05/25/00

Reviewed: 02/23/17

Revised: 03/15/17

Subject: Whole Gland Cryoablation of Prostate Cancer

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 Updates    
           

DESCRIPTION:

Whole gland cryoablation of the prostate (also known as total cryoablation, cryotherapy, or cryosurgery) is one of several methods to treat clinically localized prostate cancer. Whole gland cryoablaltion of the prostate may be considered an alternative to radical prostatectomy or external-beam radiotherapy (EBRT). Also, whole gland cryoablaltion of the prostate may be used for salvage of nonmetastatic relapse following initial therapy for clinically localized disease. Using percutaneously inserted cryoprobes, the glandular tissue is rapidly frozen and thawed to cause tissue necrosis. Cryosurgical ablation is less invasive than radical prostatectomy and recovery time may be shorter. EBRT requires multiple treatments, whereas only 1 treatment is usually required for total cryoablation.

There are several medical devices in use for ablation of prosthetic tissue that have received U.S. Food and Drug Administration (FDA) 510(k) clearance to market (e.g., AccuProbe® System modes 450, 550/530, and 600 series manufactured by Cryomedical Sciences Inc. and the Endocare Cryocare® CS manufactured by Endocare Inc.)

POSITION STATEMENT:

Whole gland cryoablation of the prostate meets the definition of medical necessity as treatment of clinically localized (organ-confined (T1, T2)) prostate cancer for the following when performed with an FDA device approved for ablation of prostate tissue:

BILLING/CODING INFORMATION:

CPT Coding:

55873

Cryosurgical ablation of the prostate (include ultrasonic guidance and monitoring)

ICD-10 Diagnoses Codes That Support Medical Necessity:

C61

Malignant neoplasm of prostate

C79.82

Secondary malignant neoplasm of genital organs

D07.5

Carcinoma in situ of prostate

Z85.46

Personal history of malignant neoplasm of prostate

REIMBURSEMENT INFORMATION:

None applicable.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No Local Coverage Determination (LCD) was found at the time of the last guideline reviewed date.

The following National Coverage Determinations (NCDs) was reviewed on the last guideline reviewed date: Cryosurgery of Prostate, (230.9) located at cms.gov.

DEFINITIONS:

Gleason Grading System (Score): a method of classifying the grade of cancer. The pathologist assigns a primary grade from 1 to 5 to the pattern occupying the greatest area of the specimen. A secondary grade is assigned to the pattern occupying the second largest area. These two grades are added to determine the Gleason score, which ranges from 2 to 10. Tumors with a Gleason score of 2 to 4 have lower biological aggressiveness, those with a score of 5 to 6 have an intermediate aggressiveness, and those with a score of 7 or higher are biologically aggressive tumors (American Urological Association, 2009).

Prostate: a gland in the male, which surrounds the neck of the bladder and the urethra. The prostate consists of a median lobe and two lateral lobes, and is made up partly of glandular matter.

Stages T1 or T2: organ-confined cancer.

Stages T3: locally advanced cancer.

Stage T2B (B2): cancer detected during digital rectal examination as a hard lump on the prostate and involves both sides of the prostate gland or is larger than 2 centimeters.

RELATED GUIDELINES:

Cryoablation of Liver Tumors, 02-40000-22
Radiofrequency Ablation of Liver Tumors, 02-40000-23

Cryosurgical Ablation of Solid Tumors Other Than Liver or Prostate Tumors, 02-99221-12

OTHER:

Other names used to report cryosurgical ablation of the prostate:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Ablation, Prostate
Cryosurgery, Prostate
Cryotherapy, Prostate
Salvage Cryotherapy
Transperineal Percutaneous Prostate Cryosurgery

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer Executive Summary Number 13, 02/08.
  2. Ahmed S, Lindsey B, Davies J. Salvage cryosurgery for locally recurrent prostate cancer following radiotherapy. Prostate Cancer and Prostatic Diseases 2005; 8: 31-35.
  3. American Cancer Society Overview: Prostate Cancer-How Is Prostate Cancer Treated? 06/27/07.
  4. American Urological Association Best Practice Policy Statement on Cryosurgery for the Treatment of Localized Prostate Cancer, 2008.
  5. American Urological Association Prostate Cancer Guideline for the Management of Clinically Localized Prostate Cancer: 2007 Update.
  6. American Urological Association Prostate-Specific Antigen Best Practice Statement: 2009 Update.
  7. American Urological Association-Cryoablation for Prostate Cancer, 2008.
  8. Aus G, Pileblad E, Hugosson J. Cryosurgical ablation of the prostate: 5-year follow-up of a prospective study. European Urology 2002; 42(2): 133-138.
  9. Barry MJ, Albertsen PC, Bagshaw MA et al. Outcomes for men with clinically nonmetastatic prostate carcinoma managed with radical prostatectoly, external beam radiotherapy, or expectant management: a retrospective analysis Cancer 2001; 91(12): 2302-2314.
  10. Blue Cross and Blue Shield Association. Technology Evaluation Center (TEC). Cryoablation for the Primary Treatment of Clinically Localized Prostate Cancer. 16(6), 2001.
  11. Blue Cross Blue Shield Association Medical Policy Whole Gland Cryoablation of Prostate Cancer 7.01.79, 10/16.
  12. Chin JL, Lim D, Abdelhady M. Review of Primary and Salvage Cryoablation for Prostate Cancer. Cancer Control 2007; 14(3): 231-237.
  13. 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.
  14. 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 International 2000;85(3):281-286.
  15. 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.
  16. Ellis DS. Cryosurgery as primary treatment for localized prostate cancer: a community hospital experience Urology 2002; 60(2 Suppl 1): 34-39.
  17. Gage AA, Baust JG. Cryosurgery for tumors. Journal of American College of Surgeons 2007; 205(2): 342-356.
  18. 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. Scientific Report. 2016;6:27490.
  19. 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 Intternational 2012;109 Suppl 1:22-29.
  20. Long JP, Bahn D, Lee F et al. Five-year retrospective, multi-institutional pooled anlaysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology 2001; 57(3): 518-523.
  21. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Prostate cancer. Version 1.2017.
  22. National Cancer Institute-Cryosurgery in Cancer Treatment, 09/13.
  23. National Cancer Institute-Prostate Cancer Treatment (PDQ®) Health Professional Version, 01/06/17.
  24. National Institute for Health and Clinical Excellence-Cryotherapy for recurrent prostate cancer, 05/05.
  25. Onik G. Image-guided Prostate Cryosurgery: State of the Art. Cancer Control 2001; 8(6): 522-531.
  26. Outcomes Vary for Prostate Cancer Patients Choosing Surgery; Overall, No treatment Proven Superior. Press Release, February 4. 2008. Agency for Healthcare Research and Quality, Rockville, MD.
  27. Ramsay CR, Adewuyi TE, Gray J, et al. Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation. Health Technology Assessment 2015;19(49):1-490.
  28. 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):4695-4704.
  29. U.S. Food and Drug Administration (FDA) 510(k) Summary-CMS AccuProbe® Models 450, 550/530 and 600 Series, 08/19/97.
  30. U.S. Food and Drug Administration (FDA) 510(k) Summary-ENDOcare CRYcare™ Cryosurgical System, 12/22/97.
  31. Williams SB, Lei Y, Nguyen PL, et al. Comparative effectiveness of cryotherapy vs brachytherapy for localised prostate cancer. BJU International 2012;110(2 Pt 2):E92-98.
  32. Wilt TJ, MacDonald R, Rutks I et al. Systematic Review: Comparative Effectiveness and Harms of Treatments for Clinically Localized Prostate Cancer. Annals of Internal Medicine 2008; 148(6): 435-448.
  33. 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.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/23/17.

GUIDELINE UPDATE INFORMATION:

05/25/00

Medical Coverage Guideline Developed.

06/15/02

Annual review. Revised description section. Added coverage criteria.

06/15/04

Scheduled review, no revisions. No longer scheduled for review.

08/15/07

Reformatted guideline. Revise coverage statement. Updated description section. Revised ICD-9 diagnoses code (185) descriptor, and updated references.

09/15/08

Scheduled review. No change in position statement, and updated references.

10/15/09

Annual review. No change in position statement, and updated references.

01/01/10

Annual HCPCS coding update. Revised descriptor for code 55873.

01/01/11

Revision; added related ICD-10 codes.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

03/15/17

Revision; Changed guideline name to Whole Gland Cryoablation of Prostate Cancer, revised description and position statement. Updated ICD-10 diagnoses codes (added C79.2, D07.5 and Z85.46). Updated other section and references.

Date Printed: August 18, 2017: 10:19 AM