|
Medical Policy: 07.01.07
Original Effective Date: November 1995
Reviewed: October 2011
Revised: April 2006
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Cryoablation is a minimally-invasive surgical technique that involves controlled freezing of the prostate gland in order to destroy cancer cells. During cryoablation of the prostate, the surrounding stroma and capillaries are damaged and subsequently have an inadequate blood supply that is believed to slow the growth of cancer.
A search in early 2011 of clinical trials (available online at: ClinicalTrials.gov) identified 4 studies on cryotherapy for prostate cancer. Biochemical failure and quality of life outcomes will be evaluated in an estimated 800 patients in the prospective, multicenter registry of salvage cryotherapy in recurrent prostate cancer (SCORE) trial (NCT00824928A). This study began in January 2007 and is currently recruiting patients. Two single-institution studies (NCT00774436 and NCT00877682) will evaluate the effectiveness of focal cryotherapy in clinically-localized prostate cancer in 50 and 100 patients. These studies have completion dates of October 2011 and April 2012, respectively. A Phase I study on the safety of focal cryotherapy in 100 low-risk, localized prostate cancer patients is being conducted in Italy and is enrolling patients by invitation only (NCT00928603).
 Top
Prior Approval:
Not applicable
Top
Policy:
Cryoablation may be considered medically necessary as primary treatment for clinically localized prostate cancer (stages T1-T3) and as salvage treatment for recurrent prostate cancer following external beam irradiation.
The available evidence for use of cryotherapy in the treatment of clinically localized (organ-confined) prostate cancer when performed as initial treatment or as salvage treatment of disease that recurs following radiation therapy is sufficient to demonstrate improvement in net health outcome. This conclusion is based on the extensive data from cohort studies and clinical input including an indirect chain of evidence and the recognition that the data for this long-used technique is similar to data for a number of accepted techniques. While the data for treatment of recurrence after radiation therapy are limited, these patients have few options; one option with recurrence is prostatectomy, which can be difficult in tissue that has been irradiated. As is also problematic in primary prostate cancer, deciding when to proceed with treatment is a complex issue. However, for patients with recurrence after radiation therapy who elect further treatment, based on the limited data available, cryosurgical treatment does appear to produce anti-tumor activity.
Top
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 55873 cryosurgical ablation of the prostate (includes ultrasonic guidance for interstitial cryosurgical probe placement).
Top
Selected References:
- Da la Taille, A, Katz, A. Cryosurgery: is it an effective option for patients failing radiation? Current Opinion in Urology 2000, 10:409-413.
- Benoit, RM, Cohen, JK, Miller, Jr, RJ. Counseling patients about cryotherapy for prostate cancer in the information age. Seminars in Urologic Oncology, Vol. 18, Number 3 (August), 2000: pp226-232.
- Beerlage, HP, Thuroff, S, Madersbacher, St., Zlotta, AR, Aus, G, de Reijke, Th.M, de la Rosette, JJMCH. Current status of minimally invasive treatment options for localized prostate carcinoma. European Urology 2000; 37:2-13.
- Bahn DK, Lee F, Badalament R, Kumar A, Greski J, Chernick M. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology. 2002 Aug;60(2 Suppl 1):3-11.
- Donnelly BJ, Saliken JC, Ernst DS, Ali-Ridha N, Brasher PM, Robinson JW, Rewcastle JC. Prospective trial of cryosurgical ablation of the prostate: five-year results. Urology. 2002 Oct;60(4):645-9
- Prepelica KL, Okeke Z, Murphy A, Katz AE. Cryosurgical ablation of the prostate. Cancer. 2005 Mar 3. Abstract retrieved March 23, 2005 from PubMed database.
- Link BA. Recent trends in surgical management of localized prostate cancer. Clinical Prostate Cancer. 2005 Sep;4(2):130-3.
- Ball AJ, Gambill B, 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 Oct;20(10):723-31.
- Babaian RJ, Donnelly B, Bahn D et al. Best Practice Statement on Cryosurgery for the Treatment of Localized Prostate Cancer. J Urol. 2008 Nov:180 (5):1993-2004. Epub 2008 Sep 25.
- Shelley M, Wilt TJ, Coles B et al. Cryotherapy for localised prostate cancer. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005010.
- Nguyen PL, D’Amico AV, Lee AK et al. Patient selection, cancer control, and complications after salvage local therapy for postradiation prostate-specific antigen failure: a systematic review of the literature. Cancer. 2007 Oct 1; 110(7):1417-28.
- Ng CK, Moussa M, Downey DB et al. Salvage cryoablation of the prostate: followup and analysis of predictive factors for outcome. J Urol. 2007 Oct; 178(4 Pt 1):1253-7; discussion 1257. Epub 2007 Aug 14.
- Donnelly BJ, Saliken JC, Brasher PM et al. A randomized trial of external beam radiotherapy vs cryoablation in patients with localized prostate cancer. Cancer. 2010 Jan 15; 116(2):323-30.
- Kimura M, Mouraviev V, Tsivian M et al. Current salvage methods for prostate cancer after failure of primary radiotherapy. BJU Int. 2010 Jan; 105(2):191-201. Epub 2009 Jul 2.
- Truesdale MD, Cheetham PJ, Hruby GW et al. An evaluation of patient selection criteria on predicting progression-free survival after primary focal unilateral nerve-sparing cryoablation for prostate cancer: recommendations for follow up. Cancer J. 2010 Sep-Oct; 16(5):544-9.
- Williams AK, Martinez CH, Lu C et al. Disease-free survival following salvage cryotherapy for biopsy-proven radio-recurrent prostate cancer. Eur Urol. 2011 Sep;60(3):405-10. Epub 2010 Dec 21.
Top
Policy History:
Date Reason Action
October 2011 Annual review Policy renewed
Top
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
|
 |
