Considerations for Selecting a Prostate MRI-US Fusion Biopsy System

Advancements in MRI-Ultrasound Fusion Biopsy have improved prostate cancer detection rates significantly beyond the systematic biopsy.¹⁻³ Now that fusion is recommended by AUA for all patients⁴ - and reimbursed - it is rapidly becoming the standard of care. This means ease of scheduling and providing patients and providers increased access to fusion will become mandatory to remain competitive.

We will examine key questions to consider when selecting a fusion biopsy system, and how factors like workflow efficiency, ease of use, and system integration can impact the fusion biopsy and implementation experience.

Initial Considerations. Starting/Upgrading an MRI-Fusion Program

The first consideration is to decide where you want to perform your prostate biopsies and with what approach - transrectal (TR) and/or transperineal (TP). Both transrectal and transperineal fusion biopsies can be done at any site - in-office, ASC or hospital. However, TP fusion will require different ultrasound equipment, lithotomy bed and stirrups, transperineal needle guides and may need anesthesia beyond a local anesthetic.

The ideal fusion biopsy system should be able to support both TR and TP biopsy approaches at any site of care, so you have the flexibility in the future to use the fusion system anywhere with any approach.

Each site of care and biopsy approach has its advantages and disadvantages. The following will all impact your decision: Ease of scheduling the MRI and fusion procedure, overall costs vs. reimbursement, impact on physician revenue, time per procedure and RVUs, staffing, patient costs and insurance coverage, and physician ownership of the site.

Your MRI-fusion equipment vendor should be able to provide a customized ROI and the advantages for each care site.

Finally, decide if you will use a service provider or own your equipment. Service providers will bring all the equipment you need and staffing but usually charge a minimum “show-up fee” plus a per procedure fee, and are only available on certain case days, limiting access. Since you must stack cases, physician efficiency is often limited to 1-2 cases per hour. If your volume is more than a few procedures per month, strong consideration should be given to owning a fusion system for provider scheduling accessibility any day of the week.

Owning your fusion equipment helps minimize scheduling interference with OR time for other procedures and optimizes physician flexibility and time. If you own the ASC, owning fusion equipment also reduces procedure costs and increases your overall fusion volume and billings significantly.

Integration with Current Equipment and Workflows. MRI, Ultrasound, Staffing and Accessories Considerations

Prostate fusion software-assisted biopsy workflow processes include multiparametric MRI (mpMRI) acquisition, identification and contouring of ROIs (regions of interest), creation of an ultrasound 3D model, fusion of MRI and US 3D models with ROI targets, probe/needle tracking, biopsy marking and reporting.⁵

Software-based registration platforms harness complex algorithms to register and display MRI and US images during biopsy, justifying higher reimbursement for fusion equipment vs. cognitive fusion, which is only reimbursed at the ultrasound-guided biopsy rate.⁶

As mpMRIs are a key component of the biopsy process, quality is important. 3T MRI or 1.5T with endorectal coil is recommended for best quality images. PET or CT imaging may also be used if the fusion system supports them.

The fusion system should allow seamless integration with your EMR, Pictures Archiving Communication Systems (PACS) and cloud-based servers such as PowerShare to ensure effective workflows. In addition, use of prostate MRI-AI software is increasing, so the software used to prepare images for fusion should have the capacity to integrate with AI-generated MRI contouring for the future.

If you have a preferred ultrasound and a preferred probe (TP, side-fire or end-fire), changing ultrasounds will add to your learning curve and costs. You should evaluate any fusion system that is permanently integrated with a proprietary ultrasound for US quality, ease of use and cost. If the MRI fusion system integrates with other ultrasounds, discover the degree of integration and automation.

For example, does the fusion system automatically…

• sync with US setting changes, or is it a manual process?

• measure and contour the entire prostate so all you have to do is approve, or do you only contour one segment and hope you have chosen the correct one to build a 3D model?  

• compensate in real-time to patient movement or do you have stop and take time to manually realign or scan to know where the needle/probe is located in the 3D model?  

• mark every biopsy without requiring a manual button or foot pedal press so you have a 100% map for treatment planning and active surveillance should a systematic biopsy core have cancer?  

• integrate with the TP guide so that you can use the fused 3D model to target ROIs, or does it require you to use the US 2D image with cognitive fusion during biopsy taking? This is especially important when lesions are small, or in difficult-to-reach locations.

Staffing Considerations: Does the system require an Ultrasound Tech, or can an OR Tech/ Medical Assistant learn to support procedures? Can the system be used by a single physician without another person in the room in a pinch? The degree of integration and automation will contribute to ease of use and lower the learning curve for physicians and staff.

Other Important Considerations for Practices

There are several other key factors that should be considered: patient needs, managing low-grade prostate cancer, the path to successful adoption, and implementation cost.

Patient Needs

Clinical Needs: Since prostate MRI-guided fusion biopsy is recommended for all patients due to its 30-50% increased high-grade cancer detection rate, it should be offered to every patient with a PIRADS score and ROIs indicating need for biopsy. If you choose to biopsy a patient without an ROI, consider using your fusion system so you have an accurate map of where systematic biopsies are taken if any cores are reported to be cancer positive. The location of the ROI(s) in anterior or apical areas may also impact the approach the physician selects.

Access/Financial Needs: Travel distance, insurance limitations and out-of-pocket costs may dictate what site is ideal for your patient. Costs are highest in hospitals, and some insurance carriers may not cover hospital biopsies and MRIs. Time to schedule and cost/location for the MRI can also impact patients, especially if they are anxious to get answers.

Low Grade Management: Active Surveillance and Focal Treatment

Focal Treatment Plans and Active Surveillance require accuracy and precision for safety. Having every biopsy marked so that it can be matched to positive cancer cores is critical.

For recommended active surveillance of low-grade cancers, the ability to overlay all previous biopsies on new MRI imaging for active surveillance is essential for understanding changes that have occurred since the last biopsy and precisely re-targeting new areas to biopsy.

Fusion biopsy systems should also empower the user to enter precise locations of cancerous areas within the biopsy cores, so they can be integrated with three-dimensional focal treatment planning to ensure safe margins. While you may not be performing focal treatment today, you should be sure the system has that capability for the future.

Biopsy preservation is another key consideration. Up to 40% of prostate biopsy tissue never makes it to the slide, so having a collection system that preserves the biopsy cores from the needle to pathology slide to reduce fragmentation and tissue loss, and ensure accurate orientation and localization of cancer for treatment planning is important.

Adoption Ease, Affordability, and Implementation

MRI-US fusion biopsy systems can be a significant investment with upfront costs of over $300,000 and additional annual costs for service, maintenance and software. Training can also be limited to just one session, depending on the vendor, resulting in added costs or users not feeling confident in the use of the system.

A fusion biopsy system that works with your existing ultrasound, offers a lower installation fee that includes all necessary accessories and training, and provides clear pay-per-procedure pricing for licenses and maintenance can make the learning curve easier, and the system more affordable while aligning costs with revenue for immediate positive cash flow.

To access a checklist with all the considerations for selecting a prostate fusion system, click here.

To learn more about how Navigo and SmartBx can help you bring advanced MRI fusion capabilities to any care site, schedule a consultation.

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Sources

1. N Engl J Med 2018 (PRECISION Study). MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis

2. JAMA 2015 Vol. 313, No. 4 Comparison of MR/Ultrasound Fusion–Guided Biopsy With Ultrasound-Guided Biopsy for the Diagnosis of Prostate Cancer

3. The Lancet 2017 (PROMIS Study)

4. Prostate Cancer Guidelines - American Urological Association

5. Das C, Netaji A, et al. MRI-Targeted Prostate Biopsy: What Radiologists Should Know. Korean J Radiol. 2020 Jun 11;21(9):1087–1094. doi: 10.3348/kjr.2019.0817.

6. PRS Network – New 2026 reimbursement coding guidance for Prostate Biopsy