Healthcare Industry News: FDA
News Release - October 13, 2022
Omeza Announces New CMS HCPCS Code for Omeza(R) Collagen Matrix
Studies of Wound Closure Rate with Novel Chronic Wound Treatment ContinueSARASOTA, Fla., Oct. 13, 2022 -- (Healthcare Sales & Marketing Network) -- Omeza today announced that the Centers for Medicare and Medicaid Services (CMS) has confirmed a HCPCS reimbursement code for Omeza® Collagen Matrix; code A2014, "Omeza collagen matrix, per 100 mg" was established to describe the product.
Omeza® Collagen Matrix is the first of its kind drug-device combination product, with a simple snap and squeeze application for chronic wounds. The FDA-cleared drug-device received a Level II Healthcare Common Procedure Coding System (HCPCS) reimbursement code paving the way for providers to receive reimbursement from Medicare.
The decision came after application was made to CMS in late 2021. Omeza Chief Commercial Santino Costanza stated, "This decision by CMS opens the doors to Omeza's innovative treatment line for millions of Americans covered by Medicare who are currently suffering from chronic wounds. Now we look forward to educating commercial payors on the health, financial and humanitarian benefits of a positive reimbursement decision."
Earlier this year the Department of Veterans Affairs Federal Supply Schedule (FSS) Service granted contract status for Omeza® Collagen Matrix. All Omeza products are available to government agencies through Marathon Medical, a prime vendor for the VA.
Currently, three US clinical trials are investigating the use of the three-product Omeza treatment product line, which includes Omeza® Collagen Matrix, for documentation of healing rates in venous ulcers, diabetic ulcers, and other chronic wounds. Concurrently, individual case studies submitted by providers testing the Omeza treatment product line on chronic wound closure in their clinical settings report an average percentage area reduction (PAR) of 60% at 4 weeks.
Omeza ® Collagen Matrix is indicated for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, superficial partial thickness burns, skin tears) and draining wounds.
Omeza ® Collagen Matrix is the first drug/device combination product to deliver an anhydrous 3- dimensional microstructure of collagen to challenging wounds. When applied to a wound surface, the snap and squeeze matrix is naturally incorporated into the wound over time. Omeza® Collagen Matrix is designed for intimate contact with both regular and irregular wound beds, to provide a conducive environment for the patient's natural wound healing process.
About Omeza
Omeza (www.omeza.com) is a skin science company pursuing equitable access to better wound care outcomes for patients at all sites of care. The company is based in Sarasota, FL USA. Inquiries from medical and health professionals should be directed to info@omezapro.com.
Source: Omeza
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