On a roll, MiMedx Group Inc. has received approval for its wound care allograft EpiFix from Medicare contractor Noridian Healthcare Solutions LLC.

The coverage from Noridian becomes effective on March 1 and brings the total Medicare Administrative Contractors (MACs) covering EpiFix to seven of the eight. The Noridian jurisdictions include Washington, Oregon, Idaho, Alaska, North Dakota, South Dakota, Montana, Wyoming, Utah, Arizona, California, Nevada and Hawaii. The only remaining MAC needed to approve EpiFix coverage is First Coast Service Options (FCSO), whose jurisdiction is the state of Florida. Thus, EpiFix, now has coverage in 49 of the 50 states.

“Noridian has approved EpiFix for both diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) that fail to respond to standard of care treatments. Two of the largest categories of chronic wounds are DFUs and VLUs,” said Parker H “Pete” Petit, chairman and CEO of MiMedx.

In the United States, approximately 1 million patients per year are reported to be suffering from DFUs and nearly 900,000 patients each year are reported to suffer from VLUs.

“The success of EpiFix in attaining coverage from the MACs and many of the commercial health plans and state Medicaid programs is based on our clinical study data presented to those health plans. Also included in this clinical data are the results from another recently completed randomized control trial that is expected to be published shortly,” said Bill Taylor, president and chief operating officer. “In this study, patients were enrolled following a two-week run-in period, after having been treated with four weeks of conventional therapy. Those patients exhibiting rapid healing (wound reduction of more than 50 percent) at the conclusion of ‘run-in period’ were excluded. EpiFix was either utilized weekly or bi-weekly on 40 patients. In both groups, EpiFix achieved wound closure in 70 percent of patients in 4 weeks. Furthermore, 92.5 percent of the overall population exhibited healing at 12 weeks with EpiFix. The mean time to closure for the weekly applications was 17 days, and 25 days for bi-weekly applications. Pooling this data with the previously published EpiFix data, on patients who did not heal with conventional therapy after four weeks of conventional therapy and a subsequent two week ‘run-in period’, EpiFix healed 52 of 64 (81%) of patients in 6 weeks, 58 of 64 (91 percent) of patients in 9 weeks, and 59 of 64 (92 percent) of patients in 12 weeks. The median time to closure of the 58 healed patients was 14 days.”

A clinical study published July 24, 2013 in the Journal of the American Medical Association Dermatology, reported that the median size of a DFU is 1.35 square centimeters and the median size of a VLU is 2.32 square centimeters.

“The legacy skin substitute products most widely approved by commercial health plans are only offered in fixed sheet sizes of approximately 40 square centimeters,” said Taylor. “This leads to a tremendous amount of wastage in treating both DFUs and VLUs. The MiMedx EpiFix allograft comes in sizes ranging from 1.5 square centimeters on up, allowing for size-appropriate grafts, particularly for these wound types.”

“Coupling the robust clinical results with the cost effectiveness of EpiFix, we expect a continuing rapid rate of health plan and state Medicaid reimbursement coverage in the months ahead,” added Petit.

Based in Marietta, Ga., MiMedx makes regenerative biomaterial products and bioimplants processed from human amniotic membrane.