CANTON, Mass., April 17, 2012 /PRNewswire via COMTEX/ -- Today Organogenesis Inc., a business leader in the regenerative medicine field, announced that Apligraf® has established improved coverage from multiple payors, improving access to care for millions of patients suffering from chronic, non-healing wounds. Apligraf is the only cell-based product with FDA approval for the treatment of both diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).
National Government Services, one of the country's largest federal health care contractors, is changing its coverage policy for Apligraf to five applications with weekly assessments for reapplications for both DFU and VLU patients.
Noridian Administrative Services, LLC, a contractor for the Medicare program, is updating the VLU coverage policy for Apligraf to treatment for patients with the presence of VLU of greater than two months duration, including one month of documented failed conservative treatment.
In Mississippi, Apligraf was added to the Mississippi Medicaid fee schedule for treatment of DFUs.
The company expects all of these changes to become effective this month. The changes will also enable physicians to treat patients with Apligraf in accordance with its FDA labeling criteria of weekly assessment and up to five applications as needed.
"This is an important milestone for the company, and a tremendous benefit for patients to be able to be treated as medically necessary with cell-based therapies," said Organogenesis President & CEO Geoff MacKay. "We are pleased that payors are evaluating clinical evidence and FDA approved indications, and starting to close the gap between FDA labeling and what is reimbursed. As regenerative medicine therapies become adopted as the standard of care, we are beginning to see wider acceptance of payors reimbursing in a way that ensures better access to care for the millions of patients with chronic wounds who need these treatments."
"Before the advent of advanced wound therapies such as Apligraf were available, the only treatment for chronic wounds like diabetic foot ulcers was conventional therapy, such as debridement, which left patients at high risk for osteomyelitis and amputations," said Paula Pons, M.D., C.W.S., Assistant Medical Director at the St. Joseph's Hospital Center for Wound Care and Hyperbaric Medicine in Fayetteville, New York. "As a specialist treating these wounds on a daily basis, I am pleased to see these improved reimbursements, which empower physicians to treat patients as medically necessary and without interference."
Apligraf is the first bio-engineered living cell-based product to have received FDA approval for treatment of diabetic foot ulcers and venous leg ulcers. Clinical studies of Apligraf application were based on up to five treatments, comprising weekly assessments and/or applications, over a 12-week period. Over 450,000 Apligraf units have been shipped to date, reaching patients around the world.
This week, Apligraf will be showcased at the 25th Annual Symposium on Advanced Wound Care and Wound Healing Society (SAWC / WHS 2012), being held April 19-22 in Atlanta, GA. Organogenesis will be featuring Apligraf at Booth #623 and its Medical Affairs team at Booth #540, as well as hosting events during the annual conference, and answering questions about increased reimbursement.
About Apligraf®Apligraf contains two layers of human living cells: a layer of differentiated keratinocytes and a layer of fibroblasts in a collagen matrix. When placed on a wound previously unresponsive to treatment, Apligraf provides cells, collagen matrix and other proteins that provide a covering that has been demonstrated to promote healing. In controlled clinical studies, Apligraf has been shown to be an effective and safe wound care treatment, superior to conventional treatments.
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