Hyalomatrix Now Eligible for Reimbursement in Several U.S. States and Regions

Hyalomatrix, a product by Bedford, Mass.-based Anika Therapeutics Inc., is now eligible for reimbursement as a skin substitute through the Centers for Medicare and Medicaid Services (CMS) in 11 states and Washington D.C. after receiving positive local coverage determination (LCD) changes in Arkansas, Colorado, Delaware, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, Texas, and Washington D.C. The product is an advanced wound care device based on hyaluronic acid technology

Hyaluronic acid (HA), which is also called hyaluronan or sodium hyaluronate, is present both in skin, where it plays a major role in tissue repair, and in cartilage and connective tissue, where it functions as a lubricant and a component of the extracellular matrix. HA is present in the body as a polymer (a linked chain of many individual HA units), is continually produced by hyaluronan synthases, and is degraded naturally by a category of enzymes called hyaluronidases. The acid has tissue regeneration properties.

“Receiving CMS reimbursement coverage in these states is an important milestone in the commercialization of Hyalomatrix,” said Charles H. Sherwood, Ph.D., president and CEO of Anika Therapeutics, which makes products for tissue protection, healing, and repair based on HA technology. “We look forward to continued progress as we expand our advanced wound care product franchise with Medline and broaden our footprint for Hyalomatrix in the United States.”

Hyalomatrix is being commercialized in the United States by Medline Industries Inc., which makes medical supplies and services across the continuum of care. Based in Danbury, Conn., the company has more than 100 specialists and clinicians dedicated exclusively to its extensive wound and skin care portfolio.

Hyalomatrix, a hyaluronic acid-rich scaffold onto which the body’s own cells reconstruct dermal tissue, has U.S. Food and Drug Administration 510(k) marketing clearance for the management of wounds including partial and full-thickness wounds, second-degree burns, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undetermined wounds, surgical wounds, trauma wounds, and draining wounds. Medline worked closely with reimbursement industry experts to expand Hyalomatrix’s clinical reach as Novitas Solutions Inc., a Medicare Administrative Contractor, published its new policy change on skin substitutes and product coverage, now including Hyalomatrix.

“Those dealing with slow-healing and chronic wounds now have a more affordable option to deliver significant clinical outcomes,” said Sissi Miao, Ph.D, MBA, vice president of advanced wound care at Medline. “When medically necessary, this new access to skin substitutes like Hyalomatrix helps empower physicians and practitioners.”