Profound Medical (NASDAQ:PROF; TSX:PRN) announced that the U.S. Centers for Medicare and Medicaid Services has issued proposed rules 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 proposed rule, TULSA will have three physician codes to account for therapy delivery, depending on whether one or two physicians are involved in the procedure.
Unlike other comparable prostate treatment procedures, which include payment for any and all post-operative visits performed in the first 90 days, TULSA will have a unique zero-day global period, indicating that the payment associated with the codes will only cover the work performed on the day TULSA is performed. This will provide TULSA physicians with the most flexibility to assess the appropriate number of visits needed by each patient, enabling safe and fast recovery.
TULSA codes have also been assigned to all three sites of service, including hospital outpatient, ambulatory surgical center, and private office/non-facility. Again, unique to TULSA, the spectrum of the location of service will ensure each patient can be treated in whatever setting they and their physician believe appropriate and convenient. For hospital payment, the proposed rule has established TULSA as a Level 6 Urology Ambulatory Payment Classification.
Comparing TULSA to robotic radical prostatectomy (RP), analyst Rahul Sarugaser, Ph.D., said, “We find that the economics for both hospitals and physicians are about equivalent. So, with this even playing field, we expect TULSA’s adoption to be driven based on its favorable safety profile relative to RP.”
Dr. Sarugaser added that, supported by head-to-head TULSA versus RP data from the CAPTAIN trial in mid-2025, TULSA should begin establishing itself as standard-of-care treatment for all stages of localized prostate disease (i.e. from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and BPH; to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer). “As such, we reiterate our Strong Buy rating.”
