Company: MDXG
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001376339-25-000009
Chunk: 61

Company: MIMEDX GROUP, INC.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 61
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 EPICORD and EPIEFFECT products in 2025 is $1,829.23. CMS assigns lower national rates to the ASC to reflect a less resource-intensive place of service. Revenue in the ASC setting constitutes less than 1% of the Company’s annual net sales. Medicare payments for most items and services, including EPIFIX and EPICORD sheet products, have been subject to sequestration reductions of approximately 2% periodically from 2013.

12

Medicare reimbursement in the physician office and associated care settings has been under increased scrutiny over the last couple of years and has led to changes in the manner in which products qualify for coverage and are reimbursed. We expect additional reimbursement changes over the course of 2025 associated with skin substitutes. Beginning in 2022, CMS announced plans to potentially change the reimbursement mechanism for skin substitutes in the physician office setting but has not proposed or enacted any national changes to the rules for these products to date. Over the last several years, a combination of rapidly escalating prices and volumes in the industry has resulted in Medicare spending on skin substitutes to increase dramatically, with annual spending in 2020 of about $500 million to a monthly run-rate of over $1 billion per month by the end of 2024.  

In response to this dramatic increase in Medicare spending, the MACs together released a proposed Local Coverage Determination (“LCD”) in April 2024 that was further refined and finalized in November 2024. This policy, which is scheduled to become effective April 13, 2025 includes lists of skin substitute products which would explicitly be eligible for coverage and those which would not, based upon prospective, peer-reviewed randomized, controlled trials (“RCTs”). 

The Company’s EPIFIX and EPICORD products are recognized in the document for having sufficient evidence for coverage, with EPIFIX listed as covered for DFUs and VLUs and EPICORD covered for DFUs. EPIEFFECT, the Company’s other primary product for the Wound markets, will not be covered under this policy initially. We are currently enrolling an RCT for EPIEFFECT designed to generate and publish the requisite evidence for coverage in the future. 

Private Payers

We have devoted considerable resources to clinical trials to support coverage and reimbursement of our products. An increasing number of private payers reimburse for EPIFIX and EPICORD in the physician office, the HOPD and the ASC settings, and we have complete national commercial coverage for the use of E