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MIMEDX’s Advocacy to Rein in Runaway Medicare Spend for Skin Substitutes Has Yielded Significant Results with Planned Implementation of LCDs

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MIMEDX Group (NASDAQ: MDXG) announces significant changes to Local Coverage Determinations (LCDs) for skin substitute grafts, effective February 12, 2025. The revised LCDs include key modifications: patient treatment applications increased from 4 to 8, and treatment duration extended from 12 to 16 weeks. Over 200 unproven skin substitutes will no longer be covered, while MIMEDX's EPIFIX® and EPICORD® remain on the covered products list. The company highlights that Medicare spending on skin substitutes has reached over $1 billion per month, representing a 20-fold increase over five years, which these changes aim to address.

MIMEDX Group (NASDAQ: MDXG) annuncia significativi cambiamenti alle Determinazioni di Copertura Locale (LCD) per i trapianti di sostituti cutanei, a partire dal 12 febbraio 2025. Le LCD riviste includono modifiche chiave: le applicazioni di trattamento per i pazienti aumentano da 4 a 8 e la durata del trattamento è estesa da 12 a 16 settimane. Oltre 200 sostituti cutanei non provati non saranno più coperti, mentre EPIFIX® e EPICORD® di MIMEDX rimangono nella lista dei prodotti coperti. L'azienda sottolinea che la spesa di Medicare per i sostituti cutanei ha superato 1 miliardo di dollari al mese, rappresentando un aumento di 20 volte in cinque anni, che questi cambiamenti mirano ad affrontare.

MIMEDX Group (NASDAQ: MDXG) anuncia cambios significativos en las Determinaciones de Cobertura Local (LCD) para injertos de sustituto dérmico, que entrarán en vigor el 12 de febrero de 2025. Las LCD revisadas incluyen modificaciones clave: las aplicaciones de tratamiento para pacientes aumentan de 4 a 8 y la duración del tratamiento se extiende de 12 a 16 semanas. Más de 200 sustitutos dérmicos no probados dejarán de estar cubiertos, mientras que EPIFIX® y EPICORD® de MIMEDX permanecerán en la lista de productos cubiertos. La compañía destaca que el gasto de Medicare en sustitutos dérmicos ha superado 1 mil millones de dólares al mes, lo que representa un aumento de 20 veces en cinco años, que estos cambios buscan abordar.

MIMEDX 그룹(NASDAQ: MDXG)은 피부 대체 이식에 대한 지역 보장 결정(LCD)의 중대한 변화를 2025년 2월 12일부터 시행한다고 발표했습니다. 수정된 LCD에는 주요 수정 사항이 포함됩니다: 환자 치료 응용 프로그램이 4개에서 8개로 증가하고, 치료 기간이 12주에서 16주로 연장됩니다. 200개 이상의 검증되지 않은 피부 대체물이 더 이상 보장되지 않으며, MIMEDX의 EPIFIX® 및 EPICORD®는 보장 제품 목록에 남아 있습니다. 회사는 Medicare의 피부 대체물에 대한 지출이 월 10억 달러를 초과했다고 강조하며, 이는 5년 동안 20배 증가한 것으로, 이러한 변화가 해결하고자 하는 문제입니다.

MIMEDX Group (NASDAQ: MDXG) annonce des changements significatifs aux Déterminations de Couverture Locale (LCD) pour les greffons de substituts cutanés, qui entreront en vigueur le 12 février 2025. Les LCD révisées incluent des modifications clés : les applications de traitement des patients passent de 4 à 8 et la durée du traitement est prolongée de 12 à 16 semaines. Plus de 200 substituts cutanés non prouvés ne seront plus couverts, tandis que les produits EPIFIX® et EPICORD® de MIMEDX restent sur la liste des produits couverts. L'entreprise souligne que les dépenses de Medicare pour les substituts cutanés ont dépassé 1 milliard de dollars par mois, représentant une augmentation de 20 fois en cinq ans, ce que ces changements visent à corriger.

MIMEDX Group (NASDAQ: MDXG) kündigt bedeutende Änderungen an den lokalen Deckungsentscheidungen (LCDs) für Hautersatztransplantate an, die am 12. Februar 2025 in Kraft treten. Die überarbeiteten LCDs umfassen wichtige Änderungen: Die Anwendungen zur Patientenbehandlung steigen von 4 auf 8 und die Behandlungsdauer wird von 12 auf 16 Wochen verlängert. Über 200 nicht nachgewiesene Hautersatzstoffe werden nicht mehr abgedeckt, während MIMEDXs EPIFIX® und EPICORD® auf der Liste der abgedeckten Produkte bleiben. Das Unternehmen hebt hervor, dass die Medicare-Ausgaben für Hautersatzstoffe über 1 Milliarde Dollar pro Monat erreicht haben, was einen Anstieg um das 20-Fache über fünf Jahre darstellt, den diese Änderungen ansprechen sollen.

Positive
  • EPIFIX® and EPICORD® products remain covered under new LCDs
  • Treatment applications increased from 4 to 8 per patient
  • Treatment duration extended from 12 to 16 weeks
  • Reduction in competition as over 200 unproven products lose coverage
Negative
  • Implementation delay until February 12, 2025

Insights

This regulatory update represents a significant shift in Medicare reimbursement policy for skin substitutes, with substantial business implications. The key changes include limiting covered products based on clinical evidence requirements and adjusting treatment parameters (8 applications over 16 weeks). The reform addresses the concerning $1 billion monthly Medicare spend, which saw a staggering 2000% increase over five years.

For MIMEDX, this development is strategically advantageous. With EPIFIX® and EPICORD® maintaining coverage status while over 200 competing products lose reimbursement eligibility, the company is positioned to capture increased market share. The emphasis on clinical evidence favors established players like MIMEDX, potentially leading to reduced competition and improved pricing power in the Medicare market segment.

The February 2025 implementation timeline gives the company adequate preparation time to optimize its market strategy and potentially capture displaced market share from products losing coverage.

Over 200 Unproven Skin Substitutes Will No Longer Be Covered Under Revised LCDs

Company to Benefit from MACs’ Commitment to Clinically Effective, Proven Products

MARIETTA, Ga., Nov. 14, 2024 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today provided the following update on the Local Coverage Determinations (“LCDs”) regarding “Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.”  

These new LCDs were originally proposed in April 2024, with a comment period that concluded in June 2024. The LCDs are now set to become effective on February 12, 2025. As a result of industry feedback, the final LCDs have been modified in the following key areas:

  • The number of separate treatment applications a patient can receive was raised from 4 to 8
  • Treatment duration increased from 12 to 16 weeks
  • Importantly, the MACs have maintained their insistence on well-powered, peer-reviewed clinical evidence as a prerequisite for reimbursement.

“I am delighted to see that our exhaustive efforts with the Centers for Medicare and Medicaid Services (“CMS”), the Medicare Administrative Contractors (“MACs”), and Congress to call attention to the massive reimbursement abuse has resulted in a first, significant step toward corrective action. The skyrocketing cost trends driven by unsavory business practices that have plagued segments of the wound care industry for the last several years are now being addressed. Presently, this spend has risen to the absurd level of over $1 billion per month, a more than 20-fold increase over the past five years. We applaud all those who took action to bring about this much needed reform,” commented Joseph H. Capper, MIMEDX Chief Executive Officer.

Mr. Capper continued, “Today’s action by the MACs represents a major step in the right direction. Additionally, we encourage CMS to take the necessary steps to address their pricing methodology as soon as possible.”

“We believe these steps will restore order and good fiscal governance to the Medicare outpatient reimbursement system, while ensuring continued patient access to clinically proven solutions. In addition to addressing and closing reimbursement loopholes, we expect these actions will benefit patient care, given the requirement that products must demonstrate efficacy with robust clinical evidence.

“As a reminder, two of our allografts – EPIFIX® and EPICORD® – are on the list of covered products. As such, we are poised to benefit given the strong clinical evidence that back our products and the finite number of suitable options eligible for coverage,” concluded Mr. Capper.

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 is dedicated to providing 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

When will MIMEDX's new LCD coverage for skin substitutes take effect?

The new Local Coverage Determinations (LCDs) for MIMEDX's skin substitute products will take effect on February 12, 2025.

How many MIMEDX products are covered under the new LCD guidelines?

Two MIMEDX products remain covered under the new LCD guidelines: EPIFIX® and EPICORD®.

What are the key changes in treatment parameters under MDXG's new LCD coverage?

The new LCD coverage increases treatment applications from 4 to 8 per patient and extends treatment duration from 12 to 16 weeks.

How much is current Medicare spending on skin substitutes according to MDXG?

According to MIMEDX, current Medicare spending on skin substitutes has reached over $1 billion per month, representing a 20-fold increase over the past five years.

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