Magnetic Resonance Imaging-Targeted Biopsy of the Prostate

POLICY NUMBER

L.7.01.448

DESCRIPTION

Before a transrectal ultrasound-guided biopsy, a magnetic resonance imaging (MRI) scan can be used to pinpoint the location of suspicious lesions in the prostate. Use of MRI permits a targeted biopsy (as opposed to a blind biopsy, which is the current standard of care). The use of an MRI-guided prostate biopsy serves two functions: (1) to identify areas in the prostate that could harbor a high-grade tumor; and (2) to divert attention from any clinically insignificant cancers not needing treatment. In accomplishing the secondary function, patients are placed into 1 of 2 categories: those only needing active surveillance and those needing definitive intervention.

Prostate Cancer

Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among men in the United States, with an estimated 299,010 new cases and 35,250 deaths to occur in 2024.

Diagnosis

Diagnosis and grading of prostate cancer are performed by taking a biopsy of the prostate gland. A prostate biopsy typically is performed in men who have an elevated prostate-specific antigen level or who present with symptoms. The purpose of the biopsy is to determine whether cancer is present and to determine the tumor grade. Tumor grade (as measured by the Gleason score) is a major determinate in whether a patient is eligible for active surveillance (lower grade tumors) or definitive intervention (higher-grade tumors). Patients in active surveillance undergo periodic follow-up prostate biopsies to assess cancer progression (upgrading of Gleason score).

Prostate biopsies are commonly performed using transrectal ultrasound (TRUS) guidance with a 12-core sampling strategy. The use of TRUS was introduced in the late 1980s. With this technique, tissue cores are obtained systematically under ultrasound guidance throughout the whole prostate, although this approach still represents blind biopsy of the prostate as to the location of possible cancer. Before 12-core sampling, 6-core (sextant) sampling was thought to miss too many cases of cancer. However, the 12-core sampling method may overdiagnose clinically insignificant disease and underdiagnose clinically significant disease. Compared with subsequent prostatectomy, TRUS underestimates tumor grade up to 40% of the time and too often detects clinically insignificant disease.

Therefore, the ideal biopsy strategy would only identify men with prostate cancer of clinical significance to direct interventional therapy, while minimizing the detection of clinically insignificant prostate cancer and the risk of consequent overtreatment.

For men undergoing an initial biopsy for an elevated prostate-specific antigen, the systematic 12-core TRUS biopsy detection rate for prostate cancer is approximately 40% to 45%. If an initial 12-core biopsy is negative, and there is still a clinical suspicion of cancer, subsequent serial 12-core biopsies may detect cancer, or, other biopsy techniques such as transperineal template–guided saturation biopsy (in which 30 to 80 cores are typically obtained) may be used. Saturation biopsy allows for anterior and apical sampling and may detect significant cancer, but it also oversamples insignificant types of cancer. In addition, transperineal biopsy requires general anesthesia and is associated with increased morbidity.

Multiparametric Magnetic Resonance ImagingMultiparametric magnetic resonance imaging (MRI) includes anatomic T2-weighted imaging for localization of the normal gland and cancer foci and two functional imaging techniques: diffusion-weighted and perfusion imaging. Multiparametric MRI evaluation permits identifying tumor location and extent, oversampling areas of interest, undersampling (or not sampling) nontarget areas, and sampling of clinically significant disease (higher grade tumors). T2-weighted images reflect the water content of tissues and can define the zonal anatomy of the prostate and the presence of prostate cancer as focal areas of low-signal intensities. The degree of intensity decrease differs with Gleason score; higher Gleason score prostate cancer shows lower signal intensities. False-positive findings can occur with benign abnormalities, including prostatitis, atrophy, fibrosis, and gland hyperplasia, or with irradiation and hormonal treatment. Diffusion-weighted images measure the random motion of water molecules. Low diffusion coefficients are associated with prostate cancer, and there is an inverse correlation between these values and Gleason scores; however, confidence intervals overlap. Perfusion imaging permits assessment of contrast kinetics in focal lesions; prostate tumors typically enhance faster and to a greater extent than the surrounding prostate; however, nonspecificity of patterns limits the usefulness of this technique in isolation.

Several methods of MRI guidance are available for prostate biopsy: cognitive (or visual), direct (in-bore), and MRI-ultrasound fusion (visual targeted or software-based targeted). Image fusion is the process of combining information from more than one image into a single image, which may be more informative than any of the images separately. Based on MRI, suspicious areas are identified (ie, regions of interest) and subjected to targeted biopsy.

With the visual method, the ultrasound operator simply aims the biopsy needle at the area of the prostate where prior MRI indicated the lesion. This method requires the MRI unit, a conventional TRUS facility, and an ultrasound operator with no additional training beyond TRUS biopsy. The disadvantage is the potential for human error in the extrapolation from MRI to TRUS without an overlay of the images.

Direct (in-bore) MRI-targeted biopsy requires the MRI tube, a fusion of a prior MRI demonstrating a lesion with a contemporaneous MRI to confirm biopsy needle location, and needles introduced into the regions of interest. Serial MRI scans are performed to confirm the biopsy needle placement. Studies have demonstrated that in-bore MRI-targeted biopsies have a median cancer detection rate significantly higher than random biopsies; however, this technique is time-consuming and costly, due to the in-bore time and the two MRI sessions necessary. In addition, only suspicious lesions are sampled, because tissues with a “normal” appearance on MRI are not obtained.

The technique MRI-TRUS fusion biopsy, done visually or using software, superimposes pre-procedure (stored) MRI over an intraprocedural (real-time) ultrasound to direct the biopsy needle to an ultrasound region of interest defined by multiparametric MRI.

The table below summarizes the MRI requirements for the 3 different MRI-guided prostate biopsy techniques described.

Techniques for MRI-Guided Prostate Biopsy

Currently, there is evidence comparing these three techniques in terms of their ability to detect overall or clinically significant prostate cancer. There is also evidence about whether the MRI-targeted biopsy should replace the systematic 12-core TRUS biopsy.

Proposed clinical indications for use of MRI-targeted prostate biopsy include: (1) as initial biopsy, (2) re-biopsy after a first negative standard biopsy in men with persistent suspicion of disease, including those with persistently increased prostate-specific antigen levels, suspicious digital rectal exam, previous biopsy with an atypical focus on histology, or extensive high-grade prostatic intraepithelial neoplasia, (3) follow-up for active surveillance to determine initial eligibility for active surveillance and assessing disease progression over time, and (4) for local recurrence post radical prostatectomy, after external-beam radiotherapy, or after high-intensity focused ultrasound.

MRI-targeted or MRI-TRUS fusion biopsy is a medical procedure that uses MRI and ultrasound devices previously approved by the U.S. Food and Drug Administration (FDA). A prostate biopsy is a surgical procedure and, as such, it is not subject to regulation by the FDA.

The FDA product code for ultrasound devices are: IYN, ITX, IYO. The FDA product code for MRI devices include: LNH, LNI, MOS.

Several MRI-US fusion software-based targeted prostate biopsy platform specifications have been cleared for marketing by the FDA through the 510(k) process. Fusion software includes: Artemis™ (Eigen), BioJet™ (D&K Technologies), BiopSee® (MedCom), Real-time Visual Sonography (Hitachi, Tokyo, Japan), UroNav™ (Invivo/Philips), Urostation® (Koelis), and Virtual Navigator (Esaote).

Related policies –

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

• Focal Treatments for Prostate Cancer

POLICY

Magnetic resonance imaging-targeted biopsy of the prostate may be considered medically necessary for diagnosis and active surveillance of prostate cancer.

POLICY EXCEPTIONS

None

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

03/17/2016: Approved by Medical Policy Advisory Committee.

06/01/2016: Policy number A.7.01.152 added.

04/09/2018: Policy description updated regarding MRI-guided prostate biopsy and prostate cancer. Policy statement revised to state that MRI-targeted biopsy of the prostate may be considered medically necessary for diagnosis and active surveillance of prostate cancer. It previously stated: MRI-targeted biopsy of the prostate is considered to be investigational. Code Reference section updated to change the coding table from investigational to medically necessary. Added the following ICD-10 diagnosis codes C61, D07.5, D40.0, and Z85.46.

08/23/2018: Policy description updated regarding techniques for MRI-guided prostate biopsy. Policy statement unchanged.

12/21/2018: Code Reference section updated to revise code description for CPT code 77021, effective 01/01/2019.

09/11/2019: Policy reviewed; no changes.

09/10/2020: Policy description updated regarding techniques for MRI-guided prostate biopsy. Policy statement unchanged.

12/10/2021: Policy description updated regarding 2021 data for prostate cancer cases. Policy statement unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

10/18/2022: Policy description updated regarding new data for prostate cancer. Policy statement unchanged.

10/05/2023: Policy reviewed; no changes.

01/21/2025: Policy updated to change the medical policy number from "A.7.01.152" to "L.7.01.448." Policy description updated regarding new data for prostate cancer. Policy statement unchanged.

01/01/2026: Code Reference section updated to add new CPT codes 55708, 55710, 55711, 55712, 55713, 55714, and 55715.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.152

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.

Medically Necessary Codes

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