MIMEDX Comments on Proposed Medicare Reimbursement Rule Changes for CY 2026

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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

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 $125.38 for all skin substitutes. While many may take issue with the proposed price, reform in this category is long overdue,” stated Joseph H. Capper, MIMEDX Chief Executive Officer.

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 $10 billion, up from approximately $1.5 billion in 2022. Reimbursement reform that restores rational market behavior and diminishes fraud, waste and abuse will serve to benefit stakeholders, taxpayers and, most importantly, patients. We look forward to providing our perspective and recommendations to CMS during the upcoming comment period, which concludes on September 13, 2025. As always, we remain focused on supporting our customers and their patients as they navigate this evolving landscape.”  

“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

What is the new Medicare reimbursement rate proposed for MDXG skin substitutes in 2026?

CMS has proposed a fixed price of $125.38 per square centimeter for all skin substitutes, replacing the current ASP methodology.

How much did Medicare spending on skin substitutes increase from 2022 to 2024?

Medicare spending on skin substitutes increased from $1.5 billion in 2022 to nearly $10 billion in 2024 in private office and associated care settings.

When will MIMEDX's new Medicare reimbursement changes take effect?

The new reimbursement changes, including the WISeR model and pending LCDs, are scheduled for implementation on January 1, 2026.

How does MIMEDX view the proposed Medicare reimbursement changes?

MIMEDX and CEO Joseph Capper welcome and support the improvements to Medicare's reimbursement of skin substitutes, viewing the company as well-positioned due to its product capabilities and clinical evidence.

What is the deadline for providing comments to CMS on the proposed changes?

The comment period for the proposed changes concludes on September 13, 2025.