MASS Coalition Welcomes Trump Order Freezing Skin Substitute LCDs
The MASS Coalition has welcomed President Trump's order to freeze regulatory guidance not yet in effect, including Medicare Local Coverage Determinations (LCDs) for skin substitute products. The freeze extends until at least April 13, 2025, allowing for further evaluation and public comment.
This decision particularly benefits Medicare beneficiaries with diabetic foot ulcers and venous leg ulcers, ensuring continued access to treatments that help prevent sepsis and amputations. The Coalition criticized the previous administration's LCD implementation process, stating it was conducted without proper stakeholder consultation and could create a healthcare crisis for diabetics by causing treatment shortages.
La Coalizione MASS ha accolto con favore l'ordine del Presidente Trump di congelare le linee guida normative non ancora in vigore, comprese le Determinazioni di Copertura Locale (LCD) per i prodotti sostitutivi della pelle. Il congelamento sarà valido fino almeno al 13 aprile 2025, consentendo una valutazione ulteriore e commenti pubblici.
Questa decisione beneficia in particolare i beneficiari di Medicare con ulcere ai piedi diabetici e ulcere venose agli arti inferiori, garantendo un accesso continuo ai trattamenti che aiutano a prevenire la sepsi e le amputazioni. La Coalizione ha criticato il processo di attuazione delle LCD della precedente amministrazione, affermando che è stato condotto senza una corretta consultazione delle parti interessate e potrebbe creare una crisi sanitaria per i diabetici causando carenze nei trattamenti.
La Coalición MASS ha dado la bienvenida a la orden del Presidente Trump de congelar la guía regulatoria que aún no está en vigor, incluidas las Determinaciones de Cobertura Local (LCD) para los productos sustitutivos de piel. El congelamiento se extenderá hasta al menos el 13 de abril de 2025, permitiendo una evaluación adicional y comentarios del público.
Esta decisión beneficia especialmente a los beneficiarios de Medicare con úlceras en los pies diabéticos y úlceras venosas en las piernas, asegurando el acceso continuo a tratamientos que ayudan a prevenir la sepsis y las amputaciones. La Coalición criticó el proceso de implementación de LCD de la administración anterior, afirmando que se llevó a cabo sin una consulta adecuada a las partes interesadas y podría crear una crisis de atención médica para los diabéticos al provocar escasez de tratamientos.
MASS 연합은 트럼프 대통령이 발효되지 않은 규제 지침, 특히 피부 대체 제품에 대한 Medicare 지역 커버리지 결정(LCD)을 동결하라는 명령을 환영했습니다. 동결은 최소한 2025년 4월 13일까지 지속되어 추가 평가 및 공개 의견을 허용합니다.
이 결정은 특히 당뇨병성 족부 궤양 및 정맥성 하지 궤양을 앓고 있는 Medicare 수혜자에게 혜택을 주어, 패혈증과 절단을 예방하는 데 도움이 되는 치료 접근을 보장합니다. 연합은 이전 행정부의 LCD 이행 프로세스를 비판하며, 이 과정이 적절한 이해관계자 상담 없이 진행되어 당뇨병 환자에게 치료 부족을 초래해 의료 위기를 초래할 수 있다고 주장했습니다.
La Coalition MASS a salué l'ordre du Président Trump de geler les directives réglementaires qui ne sont pas encore en vigueur, y compris les Déterminations de Couverture Locale (LCD) pour les produits substitutifs de la peau. Le gel s'étendra jusqu'au 13 avril 2025 au moins, permettant ainsi une évaluation supplémentaire et des commentaires du public.
Cette décision bénéficie particulièrement aux bénéficiaires de Medicare souffrant de plaies aux pieds diabétiques et d'ulcères veineux aux jambes, garantissant ainsi un accès continu à des traitements qui aident à prévenir la septicémie et les amputations. La Coalition a critiqué le processus de mise en œuvre des LCD de l'administration précédente, affirmant qu'il avait été réalisé sans une consultation appropriée des parties prenantes et pourrait provoquer une crise de santé pour les diabétiques en entraînant des pénuries de traitements.
Die MASS-Koalition hat die Anordnung von Präsident Trump begrüßt, die regulatorischen Richtlinien, die noch nicht in Kraft sind, zu stoppen, einschließlich der lokalen Deckungsentscheidungen (LCDs) für Hautersatzprodukte. Diese Pause gilt mindestens bis zum 13. April 2025 und ermöglicht eine weitere Bewertung sowie öffentliche Kommentare.
Diese Entscheidung kommt insbesondere Medicare-Begünstigten mit diabetischen Fußgeschwüren und venösen Beinulzera zugute und gewährleistet den kontinuierlichen Zugang zu Behandlungen, die helfen, Sepsis und Amputationen zu verhindern. Die Koalition kritisierte den Implementierungsprozess der LCDs der vorherigen Regierung und erklärte, dieser sei ohne angemessene Konsultation der Interessenvertreter durchgeführt worden und könnte eine Gesundheitskrise für Diabetiker verursachen, indem er zu Behandlungsengpässen führt.
- Temporary freeze on restrictive Medicare LCDs until April 13, 2025
- Continued access to skin substitute treatments for Medicare patients
- Prevention of potential treatment shortages
- Regulatory uncertainty beyond April 13, 2025
- Potential future implementation of restrictive LCDs could limit treatment access
Insights
The presidential freeze order on skin substitute LCDs marks a important regulatory development for the wound care market, with particular significance for Celularity and other companies in this space. This temporary halt until April 13, 2025, effectively preserves the current market access framework for advanced wound care products, maintaining revenue streams that were at risk from the proposed restrictive coverage determinations.
The policy implications are multifaceted:
- The freeze prevents immediate implementation of coverage restrictions that would have physician autonomy in treatment selection and potentially reduced the addressable market for skin substitute products
- For companies like Celularity, this represents a critical 90-day window to continue operating under existing coverage parameters while potentially influencing future policy direction
- The delay particularly benefits companies serving Medicare beneficiaries with diabetic foot ulcers and venous leg ulcers, preserving access to higher-margin advanced treatments
From a market perspective, this development has several key implications:
- It maintains the current competitive landscape, preventing potential market consolidation that might have occurred under more restrictive coverage policies
- Companies retain flexibility in their pricing and market access strategies during this period
- The extension provides time for stakeholders to build stronger evidence bases and engagement strategies to influence final policy decisions
Looking ahead, the industry faces three potential scenarios:
- Complete rescission of the restrictive LCDs, maintaining current market dynamics
- Modified implementation with negotiated compromises on coverage criteria
- Delayed but eventual implementation of similar restrictions, requiring business model adaptations
The immediate stabilization of market access conditions provides a favorable near-term operating environment for companies in the space, though long-term regulatory uncertainty remains a key consideration for investors.
FLORHAM PARK, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Celularity issues the following announcement on behalf of the members of the MASS Coalition:
MASS Coalition Welcomes Trump Order Freezing Skin Substitute LCDs
President Trump’s Freeze Order Applies to Skin Substitute LCDs – LCDs will not be effective until at least April 13, 2025
The MASS Coalition applauds President Trump for his bold action ordering a freeze of all regulatory guidance not yet in effect, which includes the recent Medicare Local Coverage Determinations restricting access to skin substitute products. The “Freeze Order” specifically encompasses “guidance documents,” which include the recent Skin Substitute LCDs. We thank the Department of Health and Human Services for taking the necessary steps to withdraw the LCDs until at least April 13, 2025, so that the Department can engage in further evaluation and public comment. The Department’s action is particularly good news for Medicare beneficiaries suffering from diabetic foot ulcers and venous leg ulcers. These patients will be able to access needed treatments in order to avoid sepsis and amputations that can lead to increased costs to Medicare for lengthy in-hospital treatment, as well as premature death, for at least the next two months.
As the Coalition previously noted, the LCDs are precisely the type of Biden-era behind-closed-doors regulatory action that the Freeze Order was intended to stop. The MACs, without promised stakeholder consultation and working at the behest of a few companies, operated in secret to coordinate the LCDs. In doing so, the MACs ignored the pain and suffering of everyday Americans and threaten to create a healthcare crisis for diabetics who will face an immediate shortage of treatments and end up in the hospital – creating unnecessary delays for other Americans and increasing the cost for Medicare. The MACs do not treat patients. America’s doctors and practitioners treat patients and know what works best for them. President Trump’s Freeze Order and the upcoming actions of the Department of Health and Human Services can end the prior Administration’s misuse of the regulatory process and ensure that Americans have access to skin substitute products prescribed by their physicians. By completely rescinding the LCDs, the Trump Administration can further deliver on its promise to make America healthy again and avoid the catastrophic treatment shortage set in motion by the prior Administration that would threaten the health of millions of Americans.
About MASS Coalition
The Medicare Access to Skin Substitutes Coalition (“MASS Coalition”) is comprised of wound care companies—including manufacturers, processors and distributors—that are committed to ensuring access to critical wound care products for Medicare beneficiaries and other patients suffering from diabetic foot ulcers, venous leg ulcers, pressure ulcers and other chronic wounds.
About Celularity
Celularity Inc. (Nasdaq: CELU) is a regenerative medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Its therapeutic programs target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information, visit www.celularity.com.
Investor Contact
Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com
FAQ
What is the impact of Trump's freeze order on skin substitute treatments?
How does the LCD freeze affect Medicare patients with diabetic foot ulcers?
What were the MASS Coalition's concerns about the original LCD implementation?
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