Organogenesis Inc., a global leader in advanced wound care innovations and technologies, today announced that its PuraPly™ and PuraPly Antimicrobial (AM)™ wound management products are now eligible for Medicare coverage and reimbursement in 10 states, providing coverage for an additional 7.5 million Medicare beneficiaries, following the decision by National Government Services (NGS) to retire its local coverage determination (LCD) for cellular and tissue-based products (CTPs) effective September 1, 2016.
NGS is one of the largest Medicare Administrative Contractors (MACs) in the United States, serving approximately 24 million Medicare beneficiaries in 20 states and five U.S. territories. With this change, the PuraPly product line is now available for Medicare coverage and reimbursement based on FDA labeling and packaging in Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont, and Wisconsin. PuraPly and PuraPly AM have already been approved for pass-through reimbursement in the hospital outpatient setting by the Centers for Medicare & Medicaid Services (CMS).
PuraPly and PuraPly AM are FDA 510(k)-cleared Class II medical devices indicated for acute and chronic wound management across a wide variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, and venous and diabetic ulcers. PuraPly AM provides physicians with a new option for managing wounds contaminated with bioburden.
"We applaud the NGS for retiring its local coverage determination and making it easier for millions of Medicare patients to access clinically appropriate, advanced wound management products," said Gary S. Gillheeney, Sr., President and CEO of Organogenesis. "We're excited that many more clinicians will now be able to use our versatile PuraPly product offerings to help Medicare patients more effectively manage a wide variety of acute and chronic wounds."
The announcement comes as Organogenesis executes expansion plans across multiple product areas and departments. Earlier this year, the company announced it had raised approximately $30 million in additional investment capital among existing investment partners to support a significant expansion of the company's commercial operations, sales force, PuraPly product line, and new product development in the wound care and surgical fields.
PuraPly and PuraPly AM are manufactured at the Organogenesis facility in Canton, Mass.
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