Ryoncil® Receives J-Code From Medicare & Medicaid Services (CMS) Facilitating Reimbursement and Broader Patient Access
Mesoblast (Nasdaq:MESO) announced that Medicare & Medicaid Services activated a permanent HCPCS J‑Code J3402 for Ryoncil (remestemcel‑L‑rknd) effective October 1, 2025. The J‑Code creates a standardized billing and reimbursement pathway for Ryoncil, intended to facilitate broader patient access and simplify payment for providers treating steroid‑refractory acute graft‑versus‑host disease (SR‑aGvHD) in children. The release notes Ryoncil is the first mesenchymal stromal cell product approved by the FDA and the only therapy approved for children under age 12 with SR‑aGvHD. Providers may submit claims using J3402 for dates of service on or after October 1, 2025, and are directed to ryoncil.com for coding guidance.
Mesoblast (Nasdaq:MESO) ha annunciato che i Servizi Medicare & Medicaid hanno attivato un codice J HCPCS permanente J‑Code J3402 per Ryoncil (remestemcel‑L‑rknd) con effetto a partire dal 1 ottobre 2025. Il codice J crea un percorso standardizzato di fatturazione e rimborso per Ryoncil, pensato per facilitare un accesso più ampio dei pazienti e semplificare il pagamento per i fornitori che trattano la graft‑versus‑host disease acuta resistente agli steroidi (SR‑aGvHD) nei bambini. Il comunicato specifica che Ryoncil è il primo prodotto di cellule stromali mesenchimali approvato dalla FDA e l’unica terapia autorizzata per i bambini al di sotto dei 12 anni con SR‑aGvHD. I fornitori possono inviare le richieste utilizzando J3402 per le date di servizio a partire dal 1 ottobre 2025 e sono indirizzati a ryoncil.com per le indicazioni di codifica.
Mesoblast (Nasdaq:MESO) anunció que los Servicios de Medicare y Medicaid activaron un código J HCPCS permanente J‑Code J3402 para Ryoncil (remestemcel‑L‑rknd) con efecto a partir del 1 de octubre de 2025. El código J crea una vía estandarizada de facturación y reembolso para Ryoncil, diseñada para facilitar un mayor acceso de pacientes y simplificar el pago para los proveedores que traten la enfermedad injerto contra huésped aguda resistente a esteroides (SR‑aGvHD) en niños. El comunicado menciona que Ryoncil es el primer producto de células mesenquimales aprobado por la FDA y la única terapia aprobada para niños menores de 12 años con SR‑aGvHD. Los proveedores pueden presentar reclamaciones usando J3402 para fechas de servicio a partir del 1 de octubre de 2025, y deben consultar ryoncil.com para orientación de codificación.
Mesoblast (나스닥:MESO)가 메디케어 및 메디케이드 서비스가 J‑Code J3402라는 영구 HCPCS 코드를 Ryoncil (remestemcel‑L‑rknd) 용으로 2025년 10월 1일부로 발효했다고 발표했습니다. J‑Code는 Ryoncil에 대한 표준화된 청구 및 상환 경로를 만들어 주며, 스테로이드에 저항하는 급성 이식편대숙주질환(SR‑aGvHD)를 진료하는 아동의 접근성을 확대하고 공급자의 결제 절차를 단순화하기 위한 것입니다. 발표문은 Ryoncil이 FDA에 의해 승인된 첫 번째 중간엽 기질세포 제품이며 SR‑aGvHD를 가진 12세 미만 아동을 위한 유일한 치료법이라고 명시합니다. 공급자는 2025년 10월 1일 이후의 진료일에 대해 J3402를 사용해 청구를 제출할 수 있으며, 코딩 안내를 위해 ryoncil.com으로 안내됩니다.
Mesoblast (Nasdaq:MESO) a annoncé que les Services de Medicare et Medicaid ont activé un code J HCPCS permanent J‑Code J3402 pour Ryoncil (remestemcel‑L‑rknd) à partir du 1er octobre 2025. Le code J crée une voie de facturation et de remboursement standardisée pour Ryoncil, destinée à faciliter un accès plus large des patients et à simplifier le paiement pour les prestataires traitant des maladies du greffon contre l'hôte aiguës résistantes aux stéroïdes (SR‑aGvHD) chez l'enfant. Le communiqué précise que Ryoncil est le premier produit de cellules stromales mésenchymateuses approuvé par la FDA et le seul traitement approuvé pour les enfants de moins de 12 ans atteints de SR‑aGvHD. Les prestataires peuvent soumettre des demandes en utilisant J3402 pour les dates de service à partir du 1er octobre 2025, et il est indiqué de se rendre sur ryoncil.com pour les conseils de codage.
Mesoblast (Nasdaq:MESO) gab bekannt, dass Medicare & Medicaid Services einen dauerhaften HCPCS J‑Code J3402 für Ryoncil (remestemcel‑L‑rknd) mit Wirkung zum 1. Oktober 2025 aktiviert hat. Der J‑Code schafft einen standardisierten Abrechnungs- und Erstattungspfad für Ryoncil, der darauf abzielt, den Zugang der Patienten zu verbessern und die Zahlung für Anbieter zu vereinfachen, die steroid‑resistente akute Transplantat‑gegen‑Wirt‑Krankheit (SR‑aGvHD) bei Kindern behandeln. Die Mitteilung erwähnt, dass Ryoncil das erste Produkt mesenchymaler Stammzellen ist, das von der FDA zugelassen wurde, und die einzige Therapie für Kinder unter 12 Jahren mit SR‑aGvHD. Anbieter können Ansprüche mit J3402 für Leistungsdaten ab dem 1. Oktober 2025 einreichen, und sie werden auf ryoncil.com verwiesen, um Anleitungen zur Kodierung zu erhalten.
ميس ابليس (المعروف بـ NASDAQ:MESO) أعلنت أن خدمات مديرية الضمان الصحي Medicare & Medicaid قد فعّلت رمز HCPCS دائم J‑Code J3402 لـ Ryoncil (remestemcel‑L‑rknd) اعتباراً من 1 أكتوبر 2025. يخلق رمز J مساراً موحداً للفوَاتير والتعويضات لـ Ryoncil، بهدف تسهيل وصول أوسع للمرضى وتبسيط الدفع للمقدّمين الذين يعالجون مرض رفض الزرع المطاع ضد العوامل الستيرويدية الحاد الشديد SR‑aGvHD لدى الأطفال. ويذكر البيان أن Ryoncil هو أول منتج خلايا مركزية وسيطية مُعتمد من FDA وأوحد علاج معتمد للأطفال دون سن 12 عامًا مصابين بـ SR‑aGvHD. يمكن للمقدّمين تقديم المطالبات باستخدام J3402 لتواريخ الخدمة اعتباراً من 1 أكتوبر 2025، ويُوجَّهون إلى ryoncil.com لإرشادات الترميز.
Mesoblast (纳斯达克：MESO) 宣布，Medicare & Medicaid Services 已为 Ryoncil（remestemcel‑L‑rknd）激活永久性 HCPCS 代码 J‑Code J3402，自 2025年10月1日 起生效。该 J‑Code 为 Ryoncil 创建了标准化的计费与报销路径，旨在促进更广泛的患者获取并简化对 对激素难治性急性移植物抗宿主病（SR‑aGvHD） 儿童的治疗费用支付。公告指出，Ryoncil 是 FDA 批准的第一种间充质干细胞产品，也是12岁以下 SR‑aGvHD 儿童的唯一治疗方案。提供者可在自 2025年10月1日 起的就诊日期使用 J3402 提交理赔，编码指南请访问 ryoncil.com。
- Permanent HCPCS J‑Code J3402 active Oct 1, 2025
- Standardized billing pathway now available for Ryoncil
- Ryoncil is the first FDA‑approved MSC product and only therapy for children <12 with SR‑aGvHD
- Commercial payer coverage not yet confirmed despite J‑Code availability
NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that a specific Healthcare Common Procedure Coding System (HCPCS) J-Code assigned to Ryoncil® (remestemcel-L-rknd) by United States Medicare & Medicaid Services (CMS) became active for billing and reimbursement on October 1, 2025.1 Formal recognition by CMS is a significant milestone for Ryoncil® as the product becomes easier to bill and pay for.
The new permanent J-Code, J3402, provides a standardized, clear, permanent, and specific billing pathway for Ryoncil® by Medicaid, facilitating reimbursement and broader patient access for this important therapy. Additionally, commercial payers look to the permanent J-code to update their coverage systems.
Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).2
Mesoblast Chief Executive Dr. Silviu Itescu said: “A permanent J-Code is a critical element for successful commercialization of rare disease products, ensuring more efficient billing and enabling timely access to Ryoncil® for children with life-threatening SR-aGvHD.”
Healthcare providers can begin using J3402 for claims submitted on or after October 1, 2025. For detailed coding and billing guidance, providers are encouraged to consult ryoncil.com.3
About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.
Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.
About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets.
About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
References / Footnotes
- https://www.cms.gov/files/document/r13425cp.pdf
- Please see the full Prescribing Information at www.ryoncil.com.
- Coding and coverage decisions are made by payers, and coverage cannot be guaranteed.
Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
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FAQ
What did Mesoblast (MESO) announce about Ryoncil reimbursement on October 3, 2025?
How does J‑Code J3402 affect patient access to Ryoncil (MESO)?
When can healthcare providers submit claims using J3402 for Ryoncil (MESO)?
Is Ryoncil (MESO) approved by the FDA and for which patients?
Will the J‑Code guarantee commercial payer coverage for Ryoncil (MESO)?
