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Profound Medical Announces TULSA Reimbursement Raised to Urology APC Level 7 Under CMS Outpatient Prospective Payment System (OPPS) Final Rule for CY2025

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Profound Medical announced that CMS has established the first-time Category 1 CPT® code for TULSA procedure, effective January 1, 2025. The procedure will be reimbursed at Urology APC Level 7 with $12,992 for Hospital Outpatient and $10,728 for ASCs (Medicare National Average). This represents increases of 41% and 49% respectively over previous rates, and stands 25% higher than robotic radical proctectomy. Three new CPT codes will cover different delivery methods, with a 0-day global period, allowing separate billing for pre- and post-procedure visits. TULSA will be uniquely available across all treatment settings: hospitals, ASCs, and private offices.

Profound Medical ha annunciato che il CMS ha stabilito per la prima volta un codice CPT® di Categoria 1 per la procedura TULSA, in vigore dal 1 gennaio 2025. La procedura sarà rimborsata al Livello 7 APC Urologia, con $12,992 per i pazienti ambulatoriali e $10,728 per i Centri di Chirurgia Ambulatoriale (ASC) (Media Nazionale Medicare). Questo rappresenta aumenti del 41% e del 49% rispettivamente rispetto ai tassi precedenti, ed è superiore del 25% rispetto alla prostatectomia radicale robotica. Tre nuovi codici CPT copriranno diversi metodi di somministrazione, con un periodo globale di 0 giorni, consentendo la fatturazione separata per le visite pre e post-procedura. TULSA sarà unicamente disponibile in tutti gli ambienti di trattamento: ospedali, ASC e studi privati.

Profound Medical anunció que CMS ha establecido por primera vez un código CPT® de Categoría 1 para el procedimiento TULSA, que entrará en vigor el 1 de enero de 2025. El procedimiento se reembolsará al Nivel APC 7 de Urología, con $12,992 para pacientes ambulatorios y $10,728 para ASC (Promedio Nacional de Medicare). Esto representa aumentos del 41% y 49% respectivamente sobre las tarifas anteriores, y es un 25% más alto que la prostatectomía radical robótica. Tres nuevos códigos CPT cubrirán diferentes métodos de entrega, con un período global de 0 días, lo que permite la facturación separada para las visitas antes y después del procedimiento. TULSA estará disponible de manera única en todos los entornos de tratamiento: hospitales, ASC y consultorios privados.

Profound Medical는 CMS가 2025년 1월 1일부터 TULSA 절차를 위한 최초의 카테고리 1 CPT® 코드를 설정했다고 발표했습니다. 이 절차는 비뇨기 APC 7 등급으로 재정산되며, 외래 환자에게는 $12,992, 외과 치료 센터(ASC)에는 $10,728가 지급됩니다(메디케어 전국 평균). 이는 기존 요금에 비해 각각 41% 및 49% 증가한 수치이며, 로봇 근치술보다 25% 높은 수치입니다. 세 가지 새로운 CPT 코드는 다양한 전달 방법을 커버하며, 0일의 글로벌 기간을 가지고 있어 시술 전후 방문에 대해 별도의 청구가 가능합니다. TULSA는 병원, ASC 및 개인 진료소를 포함한 모든 치료 환경에서 독특하게 제공될 것입니다.

Profound Medical a annoncé que le CMS a établi pour la première fois un code CPT® de Catégorie 1 pour la procédure TULSA, qui entrera en vigueur le 1er janvier 2025. La procédure sera remboursée au Niveau APC 7 en Urologie, avec 12 992 $ pour les patients hospitalisés et 10 728 $ pour les Centres de Chirurgie Ambulatoire (ASC) (Moyenne Nationale Medicare). Cela représente des augmentations de 41 % et 49 % respectivement par rapport aux tarifs précédents et est 25 % plus élevé que la prostatectomie radicale robotisée. Trois nouveaux codes CPT couvriront différentes méthodes d'administration, avec une période globale de 0 jour, permettant une facturation séparée pour les visites avant et après la procédure. TULSA sera disponible de manière unique dans tous les environnements de traitement : hôpitaux, ASC et cabinets privés.

Profound Medical gab bekannt, dass das CMS erstmals einen CPT®-Code der Kategorie 1 für das TULSA-Verfahren festgelegt hat, der am 1. Januar 2025 in Kraft tritt. Das Verfahren wird auf Urologie APC-Stufe 7 mit 12.992 $ für Krankenhaus-Ambulante und 10.728 $ für ambulante chirurgische Zentren (ASC) (Bundesdurchschnitt Medicare) erstattet. Dies stellt eine Erhöhung von 41% und 49% im Vergleich zu den vorherigen Sätzen dar und ist 25% höher als die robotergestützte radikale Proktoktomie. Drei neue CPT-Codes werden verschiedene Abgabeformen abdecken, mit einem globalen Zeitraum von 0 Tagen, was eine separate Abrechnung für Vor- und Nachbesuche ermöglicht. TULSA wird einzigartig in allen Behandlungsumgebungen verfügbar sein: Krankenhäuser, ASC und Privatpraxen.

Positive
  • Significant reimbursement increase: 41% for hospitals and 49% for ASCs
  • Higher reimbursement rate than competing treatments (25% above robotic radical prostatectomy)
  • Flexible billing structure with 0-day global period allowing additional revenue from separate visit charges
  • Broad accessibility across all treatment settings (hospitals, ASCs, private offices)
  • First-time CPT code establishment providing clear reimbursement pathway
Negative
  • New reimbursement rates only effective from January 1, 2025

Insights

This reimbursement update represents a significant milestone for Profound Medical. The $12,992 HOPD and $10,728 ASC reimbursement rates for TULSA are 41% and 49% higher than previously proposed, positioning the treatment 25% above robotic radical prostatectomy rates. The assignment to Level 7 Urology APC and coverage across all three sites of service (HOPD, ASC and OBL) dramatically improves accessibility and economic viability.

The 0-day global period structure allows physicians to bill separately for pre- and post-procedure visits, offering greater flexibility and potential revenue compared to competing treatments' 90-day bundled payments. This reimbursement framework significantly enhances TULSA's market positioning against traditional prostate treatments and could accelerate adoption among healthcare providers.

TULSA's technological advantages combined with this favorable reimbursement structure create a compelling value proposition. The procedure's key differentiators include:

  • Incision-free treatment with no blood loss
  • Single-session therapy
  • No hospital stay requirement
  • Preservation of urinary and sexual function
  • MRI-guided precision
The comprehensive coverage across multiple treatment settings removes significant barriers to adoption and could accelerate market penetration, particularly in outpatient facilities seeking cost-effective alternatives to traditional prostate treatments.

– TULSA to stand above all other covered prostate disease treatment modalities at Urology Level 7 reimbursement –

– First-time CPT® code reimbursement for TULSA to be effective January 1, 2025 –

TORONTO, Nov. 04, 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 released its final rule (the “Final Rule”) establishing, for the first time, a Category 1 CPT® code for the Transurethral Ultrasound Ablation (“TULSA”) procedure, effective January 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 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-procedure 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 Center (“ASC”), and Private Office/Non-Facility (“OBL”). The spectrum of the location of service will ensure TULSA 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% and 49% for hospitals and ASCs, respectively, over TULSA payments previously set in the Proposed Rule announced in July 2024 and is also 25% higher than the Final Rule for robotic radical proctectomy, a mainstream treatment modality for prostate cancer, and 41% 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 ASC’s, imaging centers, 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 CEO 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 2 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 2 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 0-day Global Period, meaning that all post-operative 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 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.

Fee Schedule (Medicare National Average):

CPT CodeDescription APC 5377: Level 7 Urology- HOPDAPC: ASC
55882TULSA Complete Procedure$12,992.42$10,728.00


Physician Fee Schedule:

CPT Code
Description
Physician Total RVUTypical 90-Day Follow-up
Physician Total RVU with Typical 90-Day Follow-Up
Facility (HOPD, ASC)Non-Facility (OBL)Facility (HOPD, ASC)Non-Facility (OBL)
51721TULSA Device Management6.4716.259.37-11.6115.84-18.0825.62-27.86
55881TULSA Treatment14.56263.05n/a14.56263.05
51721 & 55881 Total
Procedure Total21.03
279.30
9.37-11.61
30.40-32.66
288.67-290.91
(Two Physician)
 
55882TULSA Complete Procedure (One Physician)17.91272.219.37-11.6127.28-29.52281.58 - 283.82


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. The TULSA procedure, performed using the TULSA-PRO® system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. 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 quick recovery to their normal routine. 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; 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

What is the new reimbursement rate for TULSA (PROF) in hospital outpatient settings for 2025?

The new reimbursement rate for TULSA in hospital outpatient settings will be $12,992 (Medicare National Average) starting January 1, 2025.

How much higher is TULSA's (PROF) reimbursement compared to robotic radical prostatectomy?

TULSA's reimbursement rate is 25% higher than robotic radical prostatectomy in the 2025 Final Rule.

What are the new CPT codes for TULSA (PROF) procedure in 2025?

The new CPT codes are 51721 for Device Management, 55881 for Treatment (two physicians), and 55882 for Complete Procedure (single physician).

What is the ASC reimbursement rate for TULSA (PROF) in 2025?

The ASC facility payment for TULSA (CPT 55882) will be $10,728 (Medicare National Average) starting January 1, 2025.

Profound Medical Corp.

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