Profound Medical Announces Category 1 CPT Codes Proposed CY2025 Rule for TULSA to Treat Prostate Diseases
Profound Medical announced the U.S. Centers for Medicare and Medicaid Services (CMS) proposed a Category 1 CPT code for Transurethral Ultrasound Ablation (TULSA), effective January 1, 2025. This includes three physician codes for different procedural scenarios, introducing greater billing flexibility for pre and post-procedure visits.
TULSA will be recognized across Hospital Outpatient, Ambulatory Surgical Centers, and Private Offices. The proposed payments for the complete TULSA procedure are $9,208.50 for Hospital Outpatient and $7,195.00 for Ambulatory Surgical Centers.
Physician fee schedules vary based on whether one or two physicians are involved, with RVUs assigned accordingly. This move is expected to enhance the accessibility and affordability of TULSA for treating prostate diseases.
- CMS proposed Category 1 CPT code for TULSA, effective January 1, 2025.
- TULSA recognized across Hospital Outpatient, Ambulatory Surgical Centers, and Private Offices.
- Proposed payment rates: $9,208.50 for Hospital Outpatient and $7,195.00 for Ambulatory Surgical Centers.
- Greater billing flexibility for physicians for pre and post-procedure visits.
- TULSA procedures have a 0-day global period, excluding payment for post-operative visits unlike other comparable treatments.
Insights
The introduction of Category 1 CPT codes for the TULSA procedure is a significant milestone for Profound Medical Corp. This development reflects the recognition of TULSA’s clinical value and positions it as a standardized treatment option for prostate diseases. The categorization under three distinct physician codes ensures that the procedure can be tailored whether one or two physicians are involved, thus accommodating different clinical settings and preferences. The 0-day global period, which allows physicians to separately bill for pre- and post-operative visits, offers flexibility in patient management and incentivizes individual care plans.
The national average payment rates—
From a clinical perspective, the TULSA procedure's ability to offer real-time MRI guidance and customizable, incision-free ablation presents a meaningful advancement in prostate treatment. This technology not only minimizes invasiveness but also aims to preserve natural functions, which is a important consideration for patient quality of life post-treatment.
In summary, the establishment of these CPT codes is likely to enhance the clinical acceptance and utilization of TULSA, promoting its integration into mainstream urological practices.
Profound Medical's announcement regarding the new CPT codes for TULSA is an indicator of potential positive financial impact. The categorization of TULSA as a Level 6 Urology APC with facility payments set at
The detailed RVU assignments across different service sites further highlight the economic potential. With RVUs of 18.01 for a single physician’s complete procedure in a facility setting, the reimbursement rates are attractive, encouraging adoption among healthcare providers. The flexibility to bill separately for pre- and post-operative visits also allows for optimized revenue management and patient care.
Moreover, as these codes become effective from January 1, 2025, investors should anticipate a potential increase in revenue streams starting from the first quarter of 2025. This could lead to improved profitability and growth prospects for Profound Medical.
Overall, while the establishment of these CPT codes is a positive development, it’s essential for investors to monitor the actual adoption rates and subsequent financial performance closely.
TORONTO, July 11, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced that 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 January 1, 2025.
According to the proposed rule, TULSA will have 3 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 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 patient 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 their safe and fast recovery. TULSA codes have also been assigned to all three sites of service: Hospital Outpatient (“HOPD”), Ambulatory Surgical Center (“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 physician 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
The Proposed Rule for the Physician Fee Schedule has set the total Facility (HOPD or ASC) Relative Value Units (“RVU”) at 6.53 for TULSA Device Management 5x006 and 14.68 RVU for the TULSA Treatment Physician 5x007 when 2 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 TULSA Device Management 5x006 and 267.47 RVU for the TULSA Treatment Physician 5x007 when 2 physicians are involved in the TULSA procedure. If one physician performs the complete TULSA procedure, the RVU is 276.65 for 5x008.
As noted above, the TULSA procedure will have a 0-day Global Period, which does not include payment for post-operative visits, while all other comparable prostate treatment procedures include payments for post-operative visits performed in the first 90 days. The typical range of post-operative office visits would be approximately 9-11 total RVUs in the first 90-days.
The below tables summarize the proposed rule Codes, RVUs and Facility Dollar Amounts.
Facility Fee Schedule:
| CPT Code | Description | APC: HOPD | APC: ASC | ||
| 5x008 | TULSA Complete Procedure | ||||
Physician Fee Schedule:
| CPT Code | Description | Physician Total RVU | Typical 90-Day Follow-up | Physician Total RVU with typical 90-day Follow-Up | ||
| Facility (HOPD, ASC) | Non-Facility (OBL) | Facility | Non-Facility (OBL) | |||
| (HOPD, ASC) | ||||||
| 5x006 | TULSA Device Management | 6.53 | 16.50 | 9.39-11.67 | 15.92-18.20 | 25.89 - 28.17 |
| 5x007 | TULSA Treatment | 14.68 | 267.47 | n/a | 14.68 | 267.47 |
| 5x006 & 5x007 Total | Procedure Total | 21.21 | 283.97 | 9.39-11.67 | 30.60-32.88 | 293.36 - 295.64 |
| (Two Physician) | ||||||
| 5x008 | TULSA Complete Procedure (One Physician) | 18.01 | 276.65 | 9.39-11.67 | 27.40-29.68 | 286.04 - 288.32 |
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, 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 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.
Forward-Looking Statements
This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; CMS’ final CY2025 Rule for TULSA, which is currently anticipated to be published in November 2024; and the success of Profound’s U.S. commercialization strategy and activities for TULSA-PRO®. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on Profound’s operations, the demand for its products, global supply chains and economic activity in general. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
For further information, please contact:
Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849
Susan Thomas
Public Relations
sthomas@profoundmedical.com
T: 619.540.9195
FAQ
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