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BackTable / Urology / Article
Establishing a Transurethral Ultrasound Ablation (TULSA) Program for Prostate Cancer Treatment
Bryant Schmitz • May 6, 2023 • 447 hits
Transurethral ultrasound ablation (TULSA) is a new prostate cancer treatment option that uses real-time MRI thermometry to visualize treatment areas and boundaries. Transurethral ultrasound ablation may offer distinct advantages over alternative treatment options, including superior preservation of the posterior plane, and reduced risk of recto-urethral fistula. However, because the treatment requires a compatible MRI and reimbursement is still being established, implementing it in your practice may require a considerable commitment. Urologists Dr. Xioasong Meng and Dr. Aditya Bagrodia team up with radiologist Dr. Daniel Costa to discuss the advantages of transurethral ultrasound ablation in treating prostate cancer, and also explain how to establish a TULSA program for prostate cancer treatment.
This article features excerpts from the BackTable Urology Podcast. We’ve provided the highlight reel in this article, and you can listen to the full podcast below.
The BackTable Urology Brief
• Transurethral ultrasound ablation (TULSA) is a relatively new prostate cancer treatment option. It has been FDA-approved since 2019.
• The TULSA treatment is performed inside an MRI magnet using transurethral ultrasound. Real-time MRI thermometry allows for continuous visualization of treatment areas and boundaries.
• According to Dr. Meng, transurethral ultrasound ablation may provide better preservation of the posterior plane compared to other focal modalities. The urethra-out approach also reduces the risk of recto-urethral fistula, with no cases reported in around 3,000 treatments worldwide
• Building a successful TULSA program requires collaboration between urology, radiology, medical oncology, radiation oncology, and hospital administration.
• MRI compatibility is one of the foremost logistical challenges of getting started with TULSA. Software updates and technology standardization have made this less of an issue in recent years, but there can still be barriers.
• Currently, there is no billing code for transurethral ultrasound prostate ablation, affecting professional fee reimbursement. A CPT code for TULSA is expected to be established by early 2025.
• The CAPTAIN trial, a randomized study comparing surgery to TULSA, is currently accruing patients. Because TULSA is a relatively new procedure, the long-term outcome and quality of life for TULSA patients are being monitored and studied.
Table of Contents
(1) Transurethral Ultrasound Ablation: A New and Innovative Prostate Cancer Treatment Option
(2) MRI Compatibility with Transurethral Ultrasound Ablation Equipment
(3) TULSA Procedure CPT Code, Costs and Reimbursement
Transurethral Ultrasound Ablation: A New and Innovative Prostate Cancer Treatment Option
The doctors discuss transurethral ultrasound ablation (TULSA) as a new treatment option for prostate cancer. TULSA, which has been FDA-approved since 2019, is done inside an MRI magnet using ultrasound, providing real-time visual feedback and precise control over treatment areas. According to Dr. Meng, the treatment has shown advantages in preserving the posterior plane and reducing the risk of recto-urethral fistula. The doctors agree that the introduction of TULSA and other new technologies will likely change the way intermediate-risk prostate cancer is treated in the future.
[Dr. Aditya Bagrodia]
I'm really excited to have you on today. When this idea of discussing TULSA came up to me, it was a no-brainer. Daniel and Xiaosong are very thoughtful clinicians, very meticulous, and I know that as they've rolled out this program at UT Southwestern, it's been done exactly like it should, in my opinion. Really, congrats on the work that you've done today treating over 100 patients with TULSA, and really hope to pick your brains on what all lessons learned, starting the program over the last few years. Maybe just to jump on into it, why don't we just have a little introduction into TULSA as a treatment option for patients with prostate cancer?
[Dr. Xiaosong Meng]
TULSA's the new kid on the block. It's only been FDA-approved, I think, since 2019 or so. I think UT studied their program in 2020 and the difference between TULSA and some of the other modalities is it's done in boar, it's done in the MRI magnet, and it's done with ultrasound. Instead of being like HIFU, which is High-Frequency Focused Ultrasound, it's transurethral ultrasound and it's a sheet of ultrasound.
The thing I really like best, and Daniel can probably attest to this, is the amount of feedback you get from your treatment. Every five to six seconds you get MRI thermometry, you can get a really nice view of exactly [00:03:45] where you're heating, where your margins are, where your boundaries are, which I think is different compared to some of the other focal technologies we have out there. We see demand, especially a lot of these guys are engineers, really like technology, and they really like what TULSA represents and the capabilities it represents.
[Dr. Aditya Bagrodia]
Perfect. Daniel, what do you think from your end? How would you just describe this to either a patient or a colleague?
[Dr. Daniel Costa]
I think from a radiologist's perspective, the visual nature of the procedure is extremely appealing. As Xiaosong mentioned, the ability to see in real-time both the anatomy and the temperature throughout the entire prostate is extremely reassuring both for us. I think it's also a concept that the patients have when they visit with us, and you're super intrigued and excited that we are able to do that during the procedure.
[Dr. Aditya Bagrodia]
Xiaosong, if I'm not mistaken, over the course of your training and career, you've been exposed to some of the most frequently used technologies that are out there. It really is an exciting time. We have cryo, we have HIFU, we have irreversible electroporation, focal brachy, focal SBRT, and TULSA as a newer one. In addition to the visualization of your treatments, are there any other theoretical or real advantages that you perceive?
[Dr. Xiaosong Meng]
Yes. That's a good question. During residency at NYU, we did focal cryo. I also saw some HIFUs that NYU was doing. They had both programs. Then here at UT, I've started doing irreversible electroporation on the preserved trial and off-trial, as well as CAPTAIN and with TULSA. I know Neil Desai is one of our rad oncs here, talks about the MRI-LINAC and the HDR brachy program that they do with Dr. Garant. Certainly, I agree, it's a great time to be in prostate cancer. I think this is likely going to change how we treat intermediate-risk prostate cancer in the future with all these different new technologies coming on board.
I think one of the benefits obviously with TULSA is that we're going urethra out. The company's very careful about this in terms of when we're ablating near the rectum, they're very careful about making sure we don't overdraw where we want to ablate. At the moment, out of about 3,000 cases around the world, there's been no recto-urethral fistula this way. Even though I think cryo with the thermometry or the thermal couples, HIFU, the rates are coming down.
I don't think the rates of recto-urethral fistula is, I would say, are 1% or 2% with both these technologies. I think going from urethra out, it certainly gives us some benefit of avoiding the rectum. I also think when you come in, if you have to do a savage procedure, Dr. Wilburn's done two savage procedures post TULSA, the plane is not as horrible as post some of these other focal modalities, because I think we're preserving that posterior plane better.
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MRI Compatibility with Transurethral Ultrasound Ablation Equipment
The panel discusses the importance of collaboration between different departments, such as urology and radiology, in establishing a transurethral ultrasound prostate ablation program. They touch on the challenges faced in the past regarding MRI compatibility and the need for buy-in from medical oncologists and radiation oncologists. The speakers emphasize the importance of a multidisciplinary approach to ensure that patients receive the appropriate care, whether that involves TULSA, radiation, or surgery. MRI compatibility is one of the foremost logistical challenges of getting started with TULSA. Software updates and technology standardization have made this less of an issue in recent years, but there can still be barriers.
[Dr. Aditya Bagrodia]
When I started here at UC, San Diego, there's this idea of really having a whole suite of options available to patients. Of course, surgery and radiation, as I mentioned, we have HIFU, we have cryo, and we're looking at TULSA and I was like, "Oh, great. I am familiar with this procedure at least through the patients that have been treated at my previous institution in UT Southwestern and started digging into it. The first thing was that none of our MRIs at multiple hospital locations, et cetera, were compatible with the profound technology. Let's maybe run through the nitty gritty. A urologist or a group or a hospital has decided that we're going to commit to this.
What are the 101 side? Maybe I'll just throw it out there, MRI compatibility. Either you've got one that's compatible, or you need to get one that's compatible. Can you comment on that?
[Dr. Daniel Costa]
Yes, certainly a joint effort from the different departments and the hospital administration and does require the desire to work together and the ability to work together. We've talked about this in other instances. I am very comfortable, and it's a great source of joy working with urology and that is to a great extent a result of our collaboration in the targeted biopsy field. I think the targeted biopsy brought radiology and urology together for good. It's a great example of us partnering to advance the field and help the patients. It's a great opportunity to have accountability, to have urologists.
It's a great opportunity to have radiology learning from the feedback that we receive from the biopsies performed by urology and it's a great opportunity for urology to see the added value of imaging in the patients that they manage. I see that as a great opportunity for both departments to work together better than they would do separately. It is a huge building block for any focal therapy program. When it comes to building the focal therapy program, when it comes to the time, let's say, you're considering starting a TULSA program, there is a checklist to go through, and one of them you mentioned the DTA is the MRI compatibility.
The MRI compatibility used to be more an issue at the beginning when the device was just released, but the company continued to work to make their software compatible with other vendors and to different platforms from all the vendors. There are also compatibility issues when it comes to the room. You have to have like a panel that allows you to access the room. These are all things that can be sorted out if there is willingness to put an effort, but it does require some planning. I would say as of today, probably these aren't that much of an issue as they were two or three years ago both because the company has worked to address these compatibility issues but also because it's much more standardized what needs to be done.
I think it's very important that the stakeholders need to understand what they want to accomplish and why they want to embark on such a journey and go over the different technologies that exist out there and why they would choose one or the other or maybe a few of them. I think what we are learning is that there is no perfect focal therapy solution that solves, or that is able to provide great treatment for every single patient. I think as this brainstorm happens, maybe getting to a point where you're able to offer solutions that complement one another or that have the ability to truly expand the patient population that you're able to offer focal therapy would make perfect sense. I would emphasize the importance of that partnership.
As you very well said, I think you can see a TULSA patient journey in three stages. The pre-TULSA assessment that requires a lot of baseline risk stratification, vetting those patients with high-quality imaging, with imaging pathology, concordance review. Then there is the TULSA treatment day where there needs to be expertise in device handling, delineating the area to be treated, accounting for things that we talked about, gland swelling motion to make sure that you're treating the patient properly. Then there is a third stage which is the post-TULSA, it's managing a patient that had a cancer treated plus the knowledge of what are the potential complications that are specific to a TULSA procedure. When we look at those three different stages, I think you can certainly see that we need the expertise from all the stakeholders.
[Dr. Xiaosong Meng]
To echo some of Daniel's points, certainly I think some of the logistical stuff, MRI compatibility, I think the company Profound will come out and do their analysis and they'll let you know what you need or what you don't need. From a programmatic standpoint, I think you not only have urology radiology, you need buy-in from your med oncs, your rad oncs because a lot of times what we've found recently is that, like you said, these patients coming in with high-risk disease or low-risk disease or in rare cases, metastatic disease or asking for TULSA. You need to be able to have the ability to say, "No, you're not a good TULSA candidate, go see my radiation oncology colleague, go see my medical oncology colleague."
As a certain point, we're the gatekeepers that we need to make sure that these patients are getting the appropriate care regardless of where they need to go to get that care. Sometimes it's TULSA and oftentimes it's not TULSA. Sometimes they're better served by radiation, sometimes they're better served by surgery.
TULSA Procedure CPT Code, Costs and Reimbursement
The physicians address the financial aspects of establishing a transurethral ultrasound ablation program, including capital costs, disposable kits, and insurance reimbursement for the procedure. They also touch on the lack of a billing code for TULSA and the efforts being made to establish one, which could result in better reimbursement for the professional fees in the future. Currently, there is no billing code for TULSA, affecting professional fee reimbursement. A CPT code for TULSA is expected to be established by early 2025.
[Dr. Aditya Bagrodia]
I've had the good fortunate pleasure of observing the close collaboration between radiology and urology at UT Southwestern. It's unique, it's special and I think it's what allows this type of program to be rolled out in a careful and considerate way. Daniel, you mentioned the third aspect of this is commitment from hospital administration. When I think about hospital administration, I'm thinking about dollars and cents here, ballpark. What are we talking about in terms of capital costs to initiate the program and are these procedures now covered by insurance?
[Dr. Daniel Costa]
Yes, so there are lots of nuances to this answer. As of today, there is no billing code for TULSA. If the procedure is done at a hospital, the hospital can bill for C codes and most of our patients are either Medicare patients or a mixture of Medicare plus private payers. The hospital is being reasonably paid for the cost of this procedure. In regards to capital cost, the model that the company right now chose to have is you pay for the disposable kit for each patient so you don't have to buy any equipment upfront, you just pay for the disposable kit.
The lack of a billing code results in suboptimal reimbursement for the professional fees. As of today, the urologist and the radiologist involved are not properly reimbursed for this procedure. If this is in a managed care or Medicare patient, there are facilities that are choosing to have a cash pay-only approach to this and that's a different story. Now, the company is partnering with professional societies to submit an application for CPT code for TULSA and the expectation is that this would be done later this year. By early 2025 is the best-case scenario for us to be able to bill for this from a professional fee standpoint.
[Dr. Aditya Bagrodia]
I think that was a comprehensive answer to what sounds like a complicated ongoing evolving issue. Hey, I think that I've certainly learned a lot about the program, about the details of it. I think it's exciting, I think it's accessible, but it really takes a pretty serious commitment.
Podcast Contributors
Dr. Daniel Costa
Dr. Daniel Costa is a diagnostic radiologist and an associate professor of radiology at UT Southewstern in Dallas, Texas.
Dr. Xiaosong Meng
Dr. Xiaosong Meng is a urologist and assistant professor with UT Southwestern in Dallas, Texas.
Dr. Aditya Bagrodia
Dr. Aditya Bagrodia is an associate professor of urology and genitourinary oncology team leader at UC San Diego Health in California and adjunct professor of urology at UT Southwestern.
Cite This Podcast
BackTable, LLC (Producer). (2023, April 26). Ep. 94 – TULSA-PRO: A Practical Guide for Setup and Success [Audio podcast]. Retrieved from https://www.backtable.com
Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.
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