CMS issues category 1 CPT codes for TULSA procedure

The Centers for Medicare & Medicaid Services (CMS) have established category 1 Common Procedural Terminology (CPT) codes for reimbursement of the Transurethral Ultrasound Ablation (TULSA) procedure performed with the TULSA-PRO system in the treatment of patients with prostate diseases, according to a news release from Profound Medical, the developer of the device.¹

The FDA granted 510(k) clearance to TULSA-PRO in August 2019

The proposed rule grants 3 CPT codes to the procedure depending on the number of physicians involved: code 5x006 TULSA Device Management and 5x007 TULSA Treatment may be used when there are 2 physicians involved, and 5x008 TULSA Complete Procedure may be used when only 1 physician is involved.

All 3 codes will become effective on January 1, 2025.

According to Profound, “TULSA 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.”¹

The codes are also assigned to all 3 sites of service, which include the hospital outpatient (HOPD) setting, the ambulatory surgical center (ASC) setting, and the private office/non-facility setting.

In the hospital setting, the code 5x008 was given a Level 6 Urology Ambulatory Payment Classification and will be billed at $9208.50 (national average). In the ASC setting, the rate for this code is $7195.00 (national average).

The total facility (HOPD or ASC) relative value units (RVU) have been set at 6.53 RVU for 5x006, 14.68 RVU for 5x007, and 18.01 RVU for 5x008. In the private office/non-facility setting, these are set at 16.50 RVU for 5x006, 267.47 RVU for 5x007, and 276.65 RVU for 5x008.

Data on TULSA

The FDA granted 510(k) clearance to TULSA-PRO in August 2019.² The clearance was based on data from the TACT trial (TULSA-PRO Ablation Clinical Trial; NCT02766543), which demonstrated the safety and efficacy of the procedure in patients with localized prostate cancer by meeting all primary and secondary end points.³

Topline results from the study, which supported the FDA clearance, showed that 95.7% of patients achieved the primary efficacy end point of a post-treatment prostate-specific antigen (PSA) reduction of 75% or greater compared with baseline. The median PSA reduction was 94.9% among all patients included in the study.³

The trial also met its secondary efficacy end points of prostate volume reduction on 12-month MRI and histological response on 12-month 10-core prostate biopsy. Specifically, the median perfused prostate volume decreased from 41 cc at baseline to 4 cc at 12 months. Additionally, 64.9% (72 of 111 evaluable patients) achieved a complete histological response at 12 months with no evidence of any cancer. Low-volume grade group 1 disease was also observed in 14.4% (n = 16) of patients, which “has virtually no potential for metastases or cancer-related mortality,” according to Profound Medical.³

Updated data from the TACT trial were reported at the 24th Annual Meeting of the Society of Urologic Oncology, showing durable effective disease control and a favorable safety profile at 5 years.⁴

At 5-year follow-up, the median PSA level decreased to 0.6 ng/mL. Of the 115 evaluable patients, 25 (21.7%) received salvage treatment.4 Predictors of treatment failure included 1-year PSA and a visible lesion on 1-year multiparametric MRI. Quality of life measures showed that 92% (61/66) of patients recovered pad-free continence, and 87% (80/92) were able to maintain erections sufficient for penetration.

Regarding safety, 10% of men experienced a grade 3 adverse event (AE), and no grade 4 or higher AEs or rectal injury were observed at 5 years.

In total, the open-label TACT trial enrolled 115 patients across 13 clinical trial sites in the US, Canada, and Europe. The median age of patients was 65 years, and the median PSA was 6.3 ng/mL. Primary and secondary end points were determined at 12 months, with quality of life and disease control assessed up to 5 years, per protocol.

References

1. Profound Medical announces category 1 CPT codes proposed CY2025 rule for TULSA to treat prostate diseases. News release. Profound Medical Corp. Published online and accessed July 11, 2024. https://www.globenewswire.com/en/news-release/2024/07/11/2911670/33471/en/Profound-Medical-Announces-Category-1-CPT-Codes-Proposed-CY2025-Rule-for-TULSA-to-Treat-Prostate-Diseases.html

2. Profound Medical receives U.S. FDA 510(k) clearance for TULSA-PRO. News release. Profound Medical Corp. August 16, 2019. Accessed July 11, 2024. https://www.globenewswire.com/news-release/2019/08/16/1903004/0/en/Profound-Medical-Receives-U-S-FDA-510-k-Clearance-for-TULSA-PRO.html

3. Profound Medical announces positive topline results from TACT pivotal clinical trial of TULSA-PRO in patients with prostate cancer. News release. Profound Medical Corp. April 4, 2019. Accessed July 11, 2024. https://www.globenewswire.com/news-release/2019/04/04/1797449/0/en/Profound-Medical-Announces-Positive-Topline-Results-from-TACT-Pivotal-Clinical-Trial-of-TULSA-PRO-in-Patients-with-Prostate-Cancer.html

4. Eggener S, Pavlovich C, Koch M, et al. Pivotal study of mri-guided transurethral ultrasound ablation (tulsa) of localized prostate cancer: 5-year follow up. 24th Annual Meeting of the Society of Urologic Oncology. November 28 – December 1, 2023; Washington, DC. Poster 197