Mr. Stephen Kilmer reports
PROFOUND MEDICAL ANNOUNCES CATEGORY 1 CPT CODES PROPOSED CY2025 RULE FOR TULSA TO TREAT PROSTATE DISEASES
Profound Medical Corp. has noted that the
U.S. Centers for Medicare and Medicaid Services (CMS) has issued its proposed rules establishing, for the first time, a Category 1 CPT code for the transurethral ultrasound ablation (Tulsa) procedure, effective Jan. 1, 2025.
According to the proposed rule, Tulsa will have three physician codes to cover how therapy is delivered, depending on if there are one or two physicians involved in the procedure: 5x006 Tulsa Device Management and 5x007 Tulsa Treatment (when two physicians are involved in the procedure); and 5x008 Tulsa Complete Procedure (when performed by a single physician). Tulsa 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 prepatient or postpatient visit separately using existing codes. This will provide physicians with the most flexibility to assess the appropriate number of visits needed by each patient and enable his or her safe and fast recovery. Tulsa codes have also 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 patients can be treated in whatever setting they and their physicians believe appropriate and convenient for each patient.
For hospital payment, the proposed rule has established Tulsa as a Level 6 urology ambulatory payment classification (APC) for 2025 for 5x008 of $9,208.50 (national average). For ASCs, the facility payment for 5x008 will be $7,195. (national average).
The proposed rule for the physician fee schedule has set the total facility (HOPD or ASC) relative value unit (RVU) at 6.53 for 5x006 Tulsa Device Management and 14.68 RVUs for the 5x007 Tulsa Treatment physician when two physicians are involved in the Tulsa procedure. If one physician performs the complete Tulsa procedure, the RVU is 18.01 for 5x008.
The proposed rule for physician fee schedule for non-facility (OBL or private office) has set RVU at 16.50 for 5x006 Tulsa Device Management and 267.47 RVU for the 5x007 Tulsa Treatment physician when two physicians are involved in the Tulsa procedure. If one physician performs the complete Tulsa procedure, the RVU is 276.65 for 5x008.
As noted herein, the Tulsa procedure will have a zero-day global period, which does not include payment for postoperative visits, while all other comparable prostate treatment procedures include payments for postoperative visits performed in the first 90 days. The typical range of postoperative 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.
Profound is commercializing Tulsa-Pro, a technology that combines real-time MRI (magnetic resonance imaging), robotically driven transurethral ultrasound and closed-loop temperature feedback control. Tulsa-Pro is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient's natural functional abilities. Tulsa-Pro has the potential to be a flexible technology in customizable prostate ablation, including intermediate-stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large-volume benign prostatic hyperplasia (BPH). Tulsa-Pro is CE (Conformite Europeenne) marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (FDA).
Profound is also commercializing Sonalleve, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a humanitarian device exemption for the treatment of osteoid osteoma. The company is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.
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