Saturation Biopsy for Diagnosis, Staging, and Management of Prostate Cancer

POLICY NUMBER

A.7.01.121

DESCRIPTION

Saturation biopsyof the prostate, in which more cores are obtained than by standard biopsy protocol, has been proposed in the diagnosis (for initial or repeat biopsy), staging, and management of individuals with prostate cancer.

Prostate Cancer

Prostate cancer is common and is the second leading cause of cancer-related deaths in men in the United States.

DiagnosisThe diagnosis of prostate cancer is made by biopsy of the prostate gland. The approach to biopsy has changed over time, especially with the advent of prostate-specific antigen screening programs that identify cancer in prostates that are normal to palpation and to transrectal ultrasound. For patients with an elevated prostate-specific antigen level but with a normal biopsy, questions exist about subsequent evaluation since repeat biopsy specimens may be positive for cancer in a substantial percentage of patients.

In the early 1990’s, use of sextant biopsies involving six random, evenly distributed biopsies became the standard approach to diagnose prostate cancer. In the late 1990’s, as studies showed high false-negative rates for this strategy (missed cancers), approaches were developed to increase the total number of biopsies and to change the location of the biopsies. While there is disagreement about the optimal strategy, most would agree that initial prostate biopsy strategies should include at least 10 to 14 cores. Additional concerns have been raised about drawing conclusions about the stage (grade) of prostate cancer based on limited biopsy specimens. Use of multiple biopsies has also been discussed as an approach to identify tumors that may be eligible for subtotal cryoablation therapy.

At present, many practitioners use a 12- to 14-core “extended” biopsy strategy for patients undergoing initial biopsy. This extended biopsy is done in an office setting and allows for more extensive sampling of the lateral peripheral zone; a sampling of the lateral horn might increase the cancer detection rate by approximately 25%.

Another approach to increasing the number of biopsy tissue cores is “saturation” biopsy. In general, saturation biopsy is considered as more than 20 cores taken from the prostate, with an improved sampling of the anterior zones of the gland, which may be undersampled in standard peripheral zone biopsy strategies and might lead to missed cancers. Saturation biopsy might be performed transrectally or transperineally; the transperineal approach is generally performed as a stereotactic template-guided procedure with general anesthesia.

SurveillanceIn addition to diagnosis of prostate cancer, some have suggested that saturation biopsy could be a part of active surveillance (a treatment approach that involves surveillance with prostate-specific antigen, digital rectal exam, and routine prostate biopsies in men whose cancers are small and expected to behave indolently). Saturation biopsy has the potential to identify tumor grade more accurately than standard biopsy.

Saturation biopsy is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.

Indications for Whole Gland Cryoablation of Prostate Cancer  are addressed in another policy.

POLICY

Saturation biopsy, taking 20 or more core tissue samples at one time, is considered medically necessary in the diagnosis, staging, and management of prostate cancer.

POLICY EXCEPTIONS

Federal Employee Program (FEP): Saturation biopsy, taking 20 or more core tissue samples at one time, is considered investigational in the diagnosis, staging, and management of prostate cancer.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

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 Mental Health Disorders, 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 medical necessity, “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.

POLICY HISTORY

10/21/2009: Policy Added.

11/19/2009: Approved by MPAC.

12/13/2012: Policy reviewed; no changes.

03/27/2014: Policy reviewed; no changes to policy statement. Removed ICD-9 procedure code 92.39 from the Code Reference section.

12/31/2014: Code Reference section updated to revise the description of the following HCPCS code: G0416.

08/27/2015: Code Reference section updated to add ICD-10 codes.

02/29/2016: Policy description updated. Policy statement unchanged. Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to remove the following deleted HCPCS codes: G0417, G0418, and G0419.

05/31/2016: Policy number A.7.01.121 added.

08/22/2016: Policy title changed from "Saturation Biopsy for Diagnosis and Staging of Prostate Cancer" to "Saturation Biopsy for Diagnosis, Staging, and Management of Prostate Cancer." Policy description updated. Policy statement unchanged.

09/30/2016: Code Reference section updated to add the following new ICD-10 diagnosis codes: D49.59, R97.20, and R97.21. Revised code descriptions for ICD-10 diagnosis codes N40.0 and N40.1.

08/07/2017: Policy description updated. Policy statement unchanged.

08/09/2018: Policy reviewed. Policy statement unchanged. Removed deleted ICD-10 diagnosis codes D49.5 and R97.2.

08/14/2019: Policy reviewed; no changes.

08/19/2020: Policy reviewed; no changes.

08/30/2021: Policy reviewed. Policy statement unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

08/10/2022: Policy reviewed; no changes.

08/09/2023: Policy reviewed; no changes.

08/12/2024: Policy description updated to change "patients" to "individuals." Policy statement unchanged.

09/11/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.121

CODE REFERENCE

This 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.

Covered Codes 

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.