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Nuwellis Receives Increased Reimbursement Rate for Aquadex SmartFlow® Therapy from the Centers for Medicare and Medicaid

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Nuwellis (Nasdaq: NUWE) announces a significant reimbursement rate increase for its Aquadex SmartFlow therapy from the Centers for Medicare and Medicaid Services (CMS). Effective January 1, 2025, the payment rate will increase by 397% from $413 to $1,639 per day. This change involves reassigning the therapeutic ultrafiltration CPT code 0692T from APC 5241 to APC 5242, creating a better reimbursement pathway for outpatient treatment. The decision aims to expand patient access to ultrafiltration therapy and improve fluid management care in outpatient settings.

Nuwellis (Nasdaq: NUWE) annuncia un significativo aumento del tasso di rimborso per la sua terapia Aquadex SmartFlow da parte dei Centri per Medicare e Medicaid Services (CMS). Dal 1 gennaio 2025, il tasso di pagamento aumenterà del 397%, passando da 413 a 1.639 dollari al giorno. Questo cambiamento prevede la riattribuzione del codice CPT per l'ultrafiltrazione terapeutica 0692T dall'APC 5241 all'APC 5242, creando un percorso di rimborso migliore per il trattamento ambulatoriale. La decisione mira ad ampliare l'accesso dei pazienti alla terapia di ultrafiltrazione e a migliorare la gestione dei fluidi nelle strutture ambulatoriali.

Nuwellis (Nasdaq: NUWE) anuncia un aumento significativo en la tasa de reembolso para su terapia Aquadex SmartFlow por parte de los Centros de Servicios de Medicare y Medicaid (CMS). A partir del 1 de enero de 2025, la tarifa de pago aumentará en un 397%, pasando de 413 a 1.639 dólares por día. Este cambio implica la reasignación del código CPT de ultrafiltración terapéutica 0692T del APC 5241 al APC 5242, creando un mejor camino de reembolso para el tratamiento ambulatorio. La decisión tiene como objetivo ampliar el acceso de los pacientes a la terapia de ultrafiltración y mejorar la atención en la gestión de líquidos en entornos ambulatorios.

누웰리스(Nasdaq: NUWE)는 메디케어 및 메디케이드 서비스 센터(CMS)로부터 Aquadex SmartFlow 요법에 대한 상당한 환급율 증가를 발표했습니다. 2025년 1월 1일부터 지급율이 397% 증가하여 하루 413달러에서 1,639달러로 인상됩니다. 이번 변화는 치료적 초여과 CPT 코드 0692T를 APC 5241에서 APC 5242로 재지정하여 외래 치료에 대한 보다 나은 환급 경로를 만들기 위한 것입니다. 이 결정은 환자들이 초여과 요법에 접근할 수 있는 기회를 확대하고 외래 환경에서의 체액 관리 치료를 개선하는 것을 목표로 하고 있습니다.

Nuwellis (Nasdaq: NUWE) annonce une augmentation significative du taux de remboursement pour sa thérapie Aquadex SmartFlow par les Centres de services Medicare et Medicaid (CMS). À compter du 1er janvier 2025, le taux de paiement augmentera de 397 %, passant de 413 à 1 639 dollars par jour. Ce changement implique la réattribution du code CPT d'ultrafiltration thérapeutique 0692T de l'APC 5241 à l'APC 5242, créant ainsi un meilleur chemin de remboursement pour le traitement ambulatoire. Cette décision vise à élargir l'accès des patients à la thérapie par ultrafiltration et à améliorer les soins de gestion des fluides dans les milieux ambulatoires.

Nuwellis (Nasdaq: NUWE) kündigt eine erhebliche Erhöhung des Erstattungssatzes für seine Aquadex SmartFlow-Therapie von den Centers for Medicare and Medicaid Services (CMS) an. Ab dem 1. Januar 2025 wird der Zahlungssatz um 397 % von 413 USD auf 1.639 USD pro Tag erhöht. Diese Änderung umfasst die Neuzuweisung des therapeutischen Ultrafiltrations-CPT-Codes 0692T von APC 5241 zu APC 5242 und schafft einen besseren Erstattungsweg für die ambulante Behandlung. Die Entscheidung zielt darauf ab, den Patienten Zugang zur Ultrafiltrationstherapie zu erweitern und die Flüssigkeitsmanagementversorgung in ambulanten Einrichtungen zu verbessern.

Positive
  • 397% increase in Medicare/Medicaid reimbursement rate from $413 to $1,639 per day
  • Improved reimbursement pathway for outpatient treatment settings
  • Potential expansion of patient access and market reach
Negative
  • New reimbursement rate doesn't take effect until January 1, 2025

Insights

This substantial 397% increase in Medicare reimbursement from $413 to $1,639 per day represents a game-changing development for Nuwellis. The higher reimbursement rate significantly improves the economic viability of providing Aquadex SmartFlow therapy in outpatient settings, which should drive broader adoption among healthcare providers. This development addresses one of the primary barriers to widespread implementation - inadequate reimbursement coverage.

The reassignment from APC 5241 to APC 5242 demonstrates CMS's recognition of the therapy's clinical value and cost structure. This regulatory change could lead to expanded market penetration in outpatient facilities, potentially increasing Nuwellis's recurring revenue streams. The timing of implementation in January 2025 gives healthcare facilities adequate time to adjust their treatment protocols and business models to incorporate this therapy more broadly.

The reimbursement increase presents a significant market opportunity for Nuwellis. With a current market cap of just $2.6 million, this regulatory catalyst could substantially impact the company's revenue potential. The outpatient setting represents a largely untapped market for ultrafiltration therapy and improved reimbursement economics could accelerate market penetration. Healthcare providers are more likely to adopt technologies with favorable reimbursement profiles, particularly when they can reduce costly hospitalizations.

The endorsement from prominent medical institutions like Lenox Hill Hospital and Henry Ford Hospital adds credibility and could influence adoption decisions by other healthcare facilities. This development positions Nuwellis to potentially capture a larger share of the fluid management market, particularly in the growing outpatient segment.

Reimbursement rate to increase 397% per day effective January 1, 2025

New rate expected to encourage adoption of ultrafiltration therapy in the outpatient setting

MINNEAPOLIS, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical device company committed to transforming the lives of people with fluid overload, is pleased to announce that the Centers for Medicare and Medicaid Services (CMS) will reassign the Aquadex ultrafiltration code to the outpatient reimbursement level most consistent with administration of ultrafiltration therapy and cost of treatment. Effective January 1, 2025, the payment rate will increase 397% from $413 to $1,639 per day.

Nestor Jaramillo, President and CEO of Nuwellis, expressed his excitement about the new payment rate, stating, "We are thrilled with the CMS' decision to reassign the code for Aquadex SmartFlow therapy, increasing the reimbursement rate for Aquadex SmartFlow therapy. This change underscores the clinical importance and cost-effectiveness of our ultrafiltration technology and will expand patient access to this life-saving therapy. It is well understood that providing care in an outpatient setting can be a better means to manage disease and prevent costly emergency hospitalizations. This policy update is a testament to our ongoing commitment to improving patient outcomes and advancing the standard of care in fluid management. We appreciate the support and guidance provided by Maria DeVita, MD, Chief of the Nephrology Division and the Training Program Director of the Nephrology Fellowship Program at Lenox Hill Hospital, and Jennifer Cowger, MD, Section Head of Heart Failure, Transplant and Mechanical Circulatory Support at Henry Ford Hospital, throughout the process."

This increase in reimbursement corresponds with the reassignment of therapeutic ultrafiltration CPT code 0692T from APC 5241 to APC 5242. The decision by CMS marks a significant milestone in the recognition of the value and effectiveness of Aquadex SmartFlow ultrafiltration therapy for treating fluid overload in heart failure patients. The reassignment to APC 5242 will provide a reimbursement pathway for ultrafiltration therapy delivered in an outpatient setting, which will help expand the number of patients who are able to receive the therapy as part of a sub-acute or chronic disease management program.

About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or Twitter.

About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2024 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.

CONTACTS

Investors:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com


FAQ

What is the new reimbursement rate for Nuwellis (NUWE) Aquadex SmartFlow therapy?

The new reimbursement rate will be $1,639 per day, representing a 397% increase from the previous rate of $413, effective January 1, 2025.

When will the increased reimbursement rate for NUWE's Aquadex therapy take effect?

The new increased reimbursement rate will take effect on January 1, 2025.

What is the new CMS code assignment for NUWE's Aquadex ultrafiltration therapy?

The therapeutic ultrafiltration CPT code 0692T has been reassigned from APC 5241 to APC 5242.

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