Mr. Stephen Kilmer reports

PROFOUND MEDICAL ANNOUNCES TULSA REIMBURSEMENT RAISED TO UROLOGY APC LEVEL 7 UNDER CMS OUTPATIENT PROSPECTIVE PAYMENT SYSTEM (OPPS) FINAL RULE FOR CY2025

United States Centers for Medicare and Medicaid Services (CMS) has released its final rule establishing, for the first time, a Category 1 CPT code for Profound Medical Corp.'s transurethral ultrasound ablation (Tulsa) procedure, effective Jan. 1, 2025.

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: CPT 51721 Tulsa device management and CPT 55881 Tulsa treatment, when two physicians are involved in the procedure, and CPT 55882 Tulsa complete procedure, when performed by a single physician. All three Tulsa codes will have a zero-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 preprocedure or postprocedure patient visits separately using existing evaluation and management (E/M) codes. This will provide physicians with the most flexibility to assess the appropriate number of visits needed by each patient and enable their safe and fast recovery.

Uniquely for prostate treatment modalities, Tulsa codes have been assigned to all three sites of service: hospital outpatient (HOPD), ambulatory surgical centre (ASC) and private office/non-facility (OBL). The spectrum of the location of service will ensure TUTulsaLSA patients can be treated in an unrivalled number of settings.

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 per cent and 49 per cent for hospitals and ASCs, respectively, over Tulsa payments previously set in the proposed rule announced in July, 2024, and is also 25 per cent higher than the final rule for robotic radical proctectomy, a mainstream treatment modality for prostate cancer and 41 per cent higher than the 2025 payment classification for benign prostatic hyperplasia (BPH) treatments, such as aquablation.

"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 ASCs, imaging centres 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," said Arun Menawat, Profound's chief executive officer and chairman.

The final rule for the physician fee schedule has set the total facility (HOPD or ASC) relative value units (RVU) at 6.47 for CPT 51721 Tulsa device management and 14.56 RVU for CPT 55881 Tulsa treatment, when two physicians are involved in the Tulsa procedure. If one physician performs the complete Tulsa procedure, the RVU is 17.91 for CPT 55882.

The proposed rule for physician fee schedule for non-facility (OBL or private office) has set RVU at 16.25 for CPT 51721 Tulsa device management and 263.05 RVU for CPT 55881 Tulsa treatment, when two physicians are involved in the Tulsa procedure. If one physician performs the complete Tulsa procedure, the RVU is 272.21 for CPT 55882.

As noted above, the Tulsa procedure will have a zero-day global period, meaning that all postoperative visits are billed separately. This is distinct from all other comparable prostate treatments which are 90-day global period and therefore include bundled payments for all postoperative visits performed in the first 90 days. The typical range of post-operative office visits would be approximately nine to 11 total RVUs in the first 90-days.

The attached tables summarize the proposed rule codes, RVUs and facility dollar amounts.

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

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