MIMEDX’s Advocacy to Rein in Runaway Medicare Spend for Skin Substitutes Has Yielded Significant Results with Planned Implementation of LCDs
November 14 2024 - 9:15AM
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 MIMEDXMIMEDX 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 NotarianniInvestor
Relations470-304-7291mnotarianni@mimedx.com
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