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Cryoablation, also known as cryotherapy or cryosurgery, of prostate cancer is a technique in which cryoprobes are inserted percutaneously into the prostate gland to rapidly freeze and thaw tissue causing necrosis. This policy focuses on the use of total (whole gland, definitive therapy) cryoablation compared with external beam radiotherapy (EBRT), radical prostatectomy or other alternative definitive treatments for patients with organ-confined (localized) prostate cancer. Subtotal (focal) cryoablation and alternatives to this procedure, are considered in a separate medical policy.
Whole gland (also known as total) cryoablation is one of several methods available to treat clinically localized prostate cancer and may be considered an alternative to radical prostatectomy or external beam radiotherapy. It also may be used for salvage of non-metastatic relapse following initial therapy for clinically localized disease. Using percutaneously inserted cryoprobes, the glandular tissue is rapidly frozen and thawed such that tissue necrosis follows. Cryosurgical ablation is less invasive than radical prostatectomy and recovery time may be shorter. External-beam radiotherapy (EBRT) requires multiple treatments, whereas only one (1) treatment is usually required for total cryoablation.
Cryoablation of prostate cancer is a surgical procedure that uses previously approved and available cryoablation systems. As a surgical procedure cryoablation of the prostate is not subject to FDA approval.
Related medical policies -
POLICYWhole gland cryoablation of the prostate may be considered medically necessary as treatment of clinically localized (organ-confined) prostate cancer when performed
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Members specific benefit plan language.
POLICY HISTORY8/1999: Approved by Medical Policy Advisory Committee (MPAC)
9/21/2001: Policy exception deleted - For Federal Employee Program (FEP) subscribers only, cryosurgery is considered medically necessary only as a primary treatment for localized prostate cancer (cryosurgical ablation of the prostate). It is considered investigational as a treatment of last resort for prostate cancer, salvage therapy, local failures after radical prostatectomy, external beam irradiation and brachytherapy (Reference Document # 99-54IHR). - Blue Cross Blue Shield Association policy # 7.01.79 considers investigational effective 08/15/01
10/11/2001: Policy exception added
2/8/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
5/2002: Reviewed by MPAC; investigational status changed to medically necessary, Sources updated
9/20/2002: Code Reference section updated
9/5/2003: ICD-9 198.82 added, HCPCS G0160 deleted
1/30/2007: Policy reviewed, returned to investigational status to align with BCBSA policy. Covered codes moved to non-covered. ICD-9 codes 185, 198.82, and 233.4 removed. FEP policy exceptions deleted.
5/16/2007: Policy reviewed, no changes. Policy name changed to "Cryoablation of Clinically Localized Prostate Cancer." Formerly named "Cryosurgery for Prostatic Carcinoma"
6/5/2009: Policy statement section updated to include medically necessary indications for localized (organ-confined) prostate cancer as initial treatment and salvage treatment. Coding section updated: CPT code 55873 moved from non-covered to covered, ICD-9 procedure code 60.62 moved from non-covered to covered. ICD-9 diagnosis codes 185, 198.82, 233.4, V10.46 added to policy.
3/15/2010: Code Reference section updated. Description for CPT code 55873 revised 1-1-2010.
07/29/2011: Deleted "Clinically Localized" from the policy title to align with scope of policy statement. Deleted outdated references from the Sources section.
07/13/2012: Policy reviewed; no changes.
08/14/2013: Policy reviewed; no changes.
06/17/2014: Policy reviewed; description updated. Policy statement unchanged.
08/21/2015: Code Reference section updated for ICD-10.
02/15/2016: Policy title changed from "Cryoablation of Prostate Cancer" to "Whole Gland Cryoablation of Prostate Cancer." Policy description updated to remove subtotal cryoablation information from the policy. Added links to related medical policies. Medically necessary policy statement updated to add "whole gland" and to change "radiation therapy" to "radiotherapy." Removed investigational policy statement regarding subtotal prostate cryoablation. Policy guidelines updated to add medically necessary and investigative definitions.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.79
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.