MIMEDX Comments on Proposed Medicare Reimbursement Rule Changes for CY 2026
MIMEDX (NASDAQ:MDXG) has responded to CMS's proposed CY 2026 Physician Fee Schedule changes regarding skin substitute reimbursement. The new proposal suggests replacing the current ASP methodology with a fixed price of $125.38 per square centimeter for all skin substitutes.
The reform aims to address the dramatic increase in Medicare spending on skin substitutes, which surged from $1.5 billion in 2022 to nearly $10 billion in 2024. CEO Joseph H. Capper supports the reform, noting it will help combat fraud and unsavory business practices in the market.
The changes, along with the WISeR model and pending LCDs, are scheduled for implementation on January 1, 2026. MIMEDX expects to maintain its competitive position due to its product capabilities and clinical evidence.
MIMEDX (NASDAQ:MDXG) ha risposto alle modifiche proposte dal CMS per il Physician Fee Schedule del 2026 riguardanti il rimborso dei sostituti cutanei. La nuova proposta prevede di sostituire l'attuale metodologia ASP con un prezzo fisso di 125,38 dollari per centimetro quadrato per tutti i sostituti cutanei.
La riforma mira a contrastare l'aumento significativo della spesa Medicare per i sostituti cutanei, che è passata da 1,5 miliardi di dollari nel 2022 a quasi 10 miliardi nel 2024. Il CEO Joseph H. Capper sostiene la riforma, sottolineando che aiuterà a combattere frodi e pratiche commerciali scorrette nel mercato.
Le modifiche, insieme al modello WISeR e ai LCD in sospeso, sono previste per l'entrata in vigore il 1° gennaio 2026. MIMEDX prevede di mantenere la sua posizione competitiva grazie alle capacità del prodotto e alle evidenze cliniche.
MIMEDX (NASDAQ:MDXG) ha respondido a los cambios propuestos por CMS para el Physician Fee Schedule del año 2026 relacionados con el reembolso de sustitutos cutáneos. La nueva propuesta sugiere reemplazar la metodología actual ASP con un precio fijo de 125,38 dólares por centímetro cuadrado para todos los sustitutos cutáneos.
La reforma busca abordar el aumento dramático en el gasto de Medicare en sustitutos cutáneos, que pasó de 1.500 millones de dólares en 2022 a casi 10.000 millones en 2024. El CEO Joseph H. Capper apoya la reforma, señalando que ayudará a combatir el fraude y las prácticas comerciales poco éticas en el mercado.
Los cambios, junto con el modelo WISeR y los LCD pendientes, están programados para implementarse el 1 de enero de 2026. MIMEDX espera mantener su posición competitiva gracias a las capacidades de su producto y a la evidencia clínica.
MIMEDX (NASDAQ:MDXG)는 CMS가 제안한 2026 회계연도 의사 수가표 변경안에 대해 피부 대체재 상환과 관련된 입장을 밝혔습니다. 새 제안은 모든 피부 대체재에 대해 현재의 ASP 방식 대신 제곱센티미터당 125.38달러의 고정 가격을 적용하는 것을 제안합니다.
이번 개혁은 2022년 15억 달러에서 2024년 거의 100억 달러로 급증한 메디케어의 피부 대체재 지출 급증 문제를 해결하는 것을 목표로 합니다. CEO 조셉 H. 캐퍼는 이 개혁을 지지하며, 시장 내 사기 및 부정한 영업 관행을 방지하는 데 도움이 될 것이라고 밝혔습니다.
WISeR 모델과 대기 중인 LCD와 함께 이 변경 사항들은 2026년 1월 1일에 시행될 예정입니다. MIMEDX는 자사의 제품 역량과 임상 증거를 바탕으로 경쟁력을 유지할 것으로 기대하고 있습니다.
MIMEDX (NASDAQ:MDXG) a répondu aux modifications proposées par le CMS concernant le Physician Fee Schedule pour l'année 2026, relatives au remboursement des substituts cutanés. La nouvelle proposition suggère de remplacer la méthodologie ASP actuelle par un prix fixe de 125,38 dollars par centimètre carré pour tous les substituts cutanés.
La réforme vise à répondre à l'augmentation spectaculaire des dépenses Medicare pour les substituts cutanés, qui sont passées de 1,5 milliard de dollars en 2022 à près de 10 milliards en 2024. Le PDG Joseph H. Capper soutient cette réforme, soulignant qu'elle aidera à lutter contre la fraude et les pratiques commerciales douteuses sur le marché.
Les changements, ainsi que le modèle WISeR et les LCD en attente, sont prévus pour une mise en œuvre au 1er janvier 2026. MIMEDX s'attend à maintenir sa position concurrentielle grâce aux capacités de ses produits et aux preuves cliniques.
MIMEDX (NASDAQ:MDXG) hat auf die von CMS vorgeschlagenen Änderungen des Physician Fee Schedule für das Jahr 2026 bezüglich der Erstattung von Hautersatzstoffen reagiert. Der neue Vorschlag sieht vor, die derzeitige ASP-Methodik durch einen festen Preis von 125,38 US-Dollar pro Quadratzentimeter für alle Hautersatzstoffe zu ersetzen.
Die Reform zielt darauf ab, den dramatischen Anstieg der Medicare-Ausgaben für Hautersatzstoffe zu adressieren, die von 1,5 Milliarden US-Dollar im Jahr 2022 auf nahezu 10 Milliarden US-Dollar im Jahr 2024 gestiegen sind. CEO Joseph H. Capper unterstützt die Reform und betont, dass sie helfen wird, Betrug und unlautere Geschäftspraktiken auf dem Markt zu bekämpfen.
Die Änderungen, zusammen mit dem WISeR-Modell und ausstehenden LCDs, sollen am 1. Januar 2026 in Kraft treten. MIMEDX erwartet, seine Wettbewerbsposition aufgrund der Produktfähigkeiten und klinischen Evidenz beizubehalten.
- Company supports and is well-positioned for the new reimbursement structure
- Reform aims to eliminate fraud and improve market behavior
- Implementation timeline provides clear visibility through January 1, 2026
- Company's strong clinical evidence portfolio positions it favorably under new rules
- Proposed fixed reimbursement rate of $125.38 may impact revenue potential
- Significant regulatory changes could create market uncertainty
- Dramatic reduction in overall Medicare spending from $10B could affect market size
Insights
CMS's proposed fixed-price reimbursement model for skin substitutes could help MIMEDX by curbing market abuses while rewarding their clinical evidence focus.
CMS has proposed a significant shift in how Medicare will reimburse skin substitutes beginning in 2026, moving from the current Average Sales Price (ASP) methodology to a fixed price of
The timing is particularly noteworthy as this proposal aligns with other significant Medicare initiatives set to implement on January 1, 2026: the Wasteful and Inappropriate Service Reduction (WISeR) model and pending Local Coverage Determinations (LCDs). Together, these create a comprehensive approach to combat what CMS perceives as market dysfunction.
For context, skin substitutes represent a critical treatment option for chronic wounds, but the category has attracted regulatory scrutiny due to alleged abusive billing practices. The 567
While MIMEDX management appears to view this change as potentially beneficial to their competitive position, the fixed price model represents a double-edged sword for the industry. Companies with strong clinical evidence supporting their products' efficacy may benefit in a more regulated environment where clinical outcomes rather than reimbursement manipulation drive product selection. However, the flat rate approach also removes pricing premiums previously available for advanced products with superior clinical outcomes.
The Hospital Outpatient Prospective Payment System (OPPS) rules, which govern reimbursement in hospital outpatient settings, haven't yet been released but will likely follow similar reform principles when published.
New Mechanism for the Reimbursement of Skin Substitutes Aimed at Curbing Fraud, Waste and Abuse
MARIETTA, Ga., July 15, 2025 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today commented on the Centers for Medicare and Medicaid Services (“CMS”) release of the CY 2026 Physician Fee Schedule (“PFS”) proposal.
“We welcome and support improvements to Medicare’s reimbursement of skin substitutes across all care settings. The proposed rule, which was published yesterday afternoon, calls for a move away from the ASP methodology in favor of a fixed price per square centimeter of
Mr. Capper continued, “The skin substitute market has experienced a proliferation of unsavory business practices over the last several years, as referenced in several recently announced enforcement actions. Under the current reimbursement methodology, the 2024 Medicare spend for skin substitutes in the private office and associated care settings had ballooned to nearly
“Importantly, MIMEDX is well-positioned to excel in an environment in which product capabilities, supported by robust clinical evidence, determine selection and usage. The recently announced Wasteful and Inappropriate Service Reduction (“WISeR”) model, the pending Local Coverage Determinations (“LCDs”), and now the PFS rules are all set for implementation on January 1, 2026. We plan to discuss this topic in more detail on our upcoming second quarter earnings call,” concluded Mr. Capper.
The CY 2026 Hospital Outpatient Prospective Payment System (“OPPS”), while mentioned extensively in the PFS, has not yet been published but is also expected to be released in proposed form and slated for implementation on January 1, 2026.
About MIMEDX
MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX provides a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. For additional information, please visit www.mimedx.com.
Contact:
Matt Notarianni
Investor Relations
470-304-7291
mnotarianni@mimedx.com
FAQ
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