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MIMEDX Comments on Recent Data Brief Published by Office of Inspector General

Key Takeaway: MiMedx Group, Inc. applauded a recent OIG report addressing compliance issues among skin substitute manufacturers regarding Medicare reimbursement. The report advocates for a transition to ASP-based payments to curb excessive costs. MIMEDX highlighted its commitment to transparent pricing with its products, EPIFIX® and EPICORD®, which align with ASP guidelines. The company supports further measures by CMS to enhance compliance and reduce financial burdens on the Medicare Trust Fund.

Market Sentiment Analysis

POSITIVE FACTORS

  • MIMEDX supports the OIG report recommending ASP payments.
  • The company emphasizes the importance of transparent pricing.
  • MIMEDX's products are acknowledged for their compliance with ASP payment rates.
  • The company has a strong focus on addressing unmet clinical needs.

CONCERNS & RISKS

  • The article mentions problematic expenditure issues in Medicare reimbursement.
  • Concerns about manufacturers withholding pricing information from CMS.
  • The ongoing need for compliance enforcement is acknowledged as a challenge.

Full Press Release Details

MARIETTA, Ga., March 16, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a pioneer and leader in placental biologics, today applauded the recent report published by OIG entitled, “Some Skin Substitute Manufacturers Did Not Comply with New ASP Reporting Requirements.” The report, which can be accessed on the U.S. Department of Health and Human Services’ website, details extensive problematic expenditure issues associated with the current Medicare reimbursement landscape in the private physician office setting for some skin substitute products. In alignment with many industry stakeholders, including MIMEDX, the report recommends all skin substitute products transition to ASP-based payments as soon as possible in an effort to substantially reduce Medicare expenditures for these products.
“At MIMEDX, we are focused on ensuring our industry-leading portfolio of placental biologic products are readily available to patients suffering from hard-to-heal wounds,” stated Joseph H. Capper, MIMEDX Chief Executive Officer. “In the private physician office setting, our EPIFIX® and EPICORD® products have been and continue to be sold and reimbursed using transparent ASP-based payment rates, which we provide to CMS each quarter. When manufacturers withhold pricing information from CMS in an effort to capitalize on higher reimbursement rates, and at the same time provide financial incentives to physicians, this creates a large and unnecessary expense burden on the Medicare Trust Fund. We are encouraged that OIG and CMS are evaluating changes that could bring transparent pricing for all skin substitute products to the private office setting. We wholeheartedly support a level playing field for Advanced Wound Care products, where products are selected for patients based upon the strongest clinical evidence available.”
In its report, OIG acknowledges the ongoing work CMS is doing to consider options around different payment approaches for skin substitutes and encourages CMS to address the disproportionate share of non-ASP payments as quickly as possible, including a potential interim solution to enforce manufacturer compliance until final rulemaking is determined. MIMEDX commends the OIG analysis and remains supportive of measures that solidify ASP-based payment methodologies, viewing this as the best way to preserve Medicare Trust Fund expenditures for these advanced products.
MIMEDX is a pioneer and leader in placental biologics, developing and distributing placental tissue allografts to help address unmet clinical needs in multiple sectors of healthcare, including the Advanced Wound Care market as well as in surgical recovery settings. MIMEDX is also focused on advancing a promising late-stage pipeline opportunity targeted at decreasing pain and improving function for patients with knee osteoarthritis. Our products are derived from human placental tissues and processed using our proprietary methods, including the Company’s own PURION® process. We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts. MIMEDX has supplied over two million allografts, through both direct and consignment shipments. For additional information, please visit www.mimedx.com.

Frequently Asked Questions

What is the recent OIG report about skin substitutes?

The OIG report highlights compliance issues with Medicare reimbursement for skin substitutes.

How does MIMEDX support ASP-based payments?

MIMEDX endorses ASP-based payments to reduce Medicare costs for skin substitute products.

What products does MIMEDX offer?

MIMEDX offers EPIFIX® and EPICORD® among other placental biologic products.

How does MIMEDX ensure product safety?

MIMEDX follows strict manufacturing practices and processes to ensure allograft safety.

What other areas does MIMEDX focus on?

MIMEDX targets advanced wound care and knee osteoarthritis pain management.

Last updated: Mar 16, 2023