Profound Medical (NASDAQ:PROF; TSX:PRN) announced that the U.S. Centers for Medicare and Medicaid Services has issued its final rule establishing, for the first time, a Category 1 CPT code for the Transurethral Ultrasound Ablation (TULSA) procedure, effective January 1, 2025.
TULSA employs real-time MR guidance for pixel-by-pixel precision to preserve prostate disease patients’ urinary continence and sexual function while killing the targeted prostate tissue via a precise sound absorption technology that gently heats it to kill temperature (55-57°C). TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure, no hospital stay is required, and most TULSA patients report a quick recovery to their normal routine.
According to the final rule, TULSA will have three codes to cover how therapy is delivered depending on if there are one or two physicians involved in the procedure. All three TULSA codes will have a 0-day global period, indicating that the payment associated with the codes will only cover the work performed on the day TULSA is performed. Physicians will thereby bill for any pre- or post-procedure patient visits separately using existing evaluation and management (E/M) codes.
Uniquely for prostate treatment modalities, TULSA codes have been assigned to all three sites of service: Hospital Outpatient (HOPD), Ambulatory Surgical Center (ASC), and Private Office/Non-Facility (OBL).
For hospital payment, the final rule has established TULSA CPT 55882 as a Level 7 Urology Ambulatory Payment Classification (APC) for 2025 of $12,992 (Medicare National Average). For ASCs, the facility payment for CPT 55882 will be $10,728 (Medicare National Average).
This represents increases of approximately 41% and 49% for hospitals and ASCs, respectively, over TULSA payments previously set in the Proposed Rule announced by CMS in July 2024 and is also 25% higher than the 2025 final rule for Intuitive Surgical’s (NASDAQ:ISRG) robotic radical proctectomy, a mainstream treatment modality for prostate cancer, and 41% higher than the 2025 payment classification for benign prostatic hyperplasia (BPH) treatments, such as PROCEPT BioRobotics’ (NASDAQ:PRCT) Aquablation procedure.
Commenting on the CMS final rule, Profound CEO, Arun Menawat, said in a statement, “We are delighted to see that CMS recognized the value proposition of the TULSA procedure and placed it in Urology APC Level 7. The codes will be applicable in the widest possible range of treatment settings, including hospitals and ASC’s, imaging centers, and office settings, such as large urology practices.”
“Clinically, TULSA is being used today at leading hospitals primarily for whole- and partial-gland treatment of a variety of prostate cancer grades and/or as relief from symptoms of BPH in certain patients who would otherwise need surgical interventions. We are pleased to bring to market an innovative procedure like TULSA that completely changes patient care from major surgery that can cause significant side effects to incision-free intervention with no blood loss, no hospital stay and preservation of patients’ vital functions,” Dr. Menawat added.
