LANGHORNE, Pa., April 16, 2015 (GLOBE NEWSWIRE) — Alliqua BioMedical, Inc. (Nasdaq:ALQA) (“Alliqua” or “the Company”), a provider of advanced wound care products, today announced that Alliqua’s Biovance® Human Amniotic Membrane Allograft, has received coverage from Novitas Solutions, Inc. (“Novitas”), a Medicare Administrative Contractor, or “MAC”.
Novitas is one of eight MACs that are responsible for processing Medicare claims in one or more of twelve geographic areas, or “jurisdictions,” in the United States. In addition to processing claims, each MAC is also responsible for issuing local coverage determinations (“LCDs”) that specify which health care products and services are reimbursable through the Medicare Fee-for-Service program in the regions under its jurisdiction.
On Friday, April 10th, Novitas Solutions, Inc. published a local coverage determination titled “Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds (L27549),”1 which included Alliqua’s Biovance Human Amniotic Membrane Allograft. Novitas has jurisdiction in two geographic areas, including eleven states and the District of Columbia. This LCD was effective for services performed on or after April 9, 2015. 
“We are extremely pleased with the recent announcement from Novitas, the first MAC to include our Biovance Human Amniotic Membrane Allograft in a local coverage determination,” said Brad Barton, Chief Operating Officer of Alliqua. “Novitas is responsible for approximately 11.3 million Medicare beneficiaries within its jurisdictions. This local coverage determination from Novitas allows physicians and wound care practitioners to offer Biovance to their Medicare beneficiaries, and we view this announcement as another important step towards our goal of obtaining comprehensive reimbursement coverage in the outpatient market setting.”
Background:
In November 2013, Alliqua entered into an exclusive licensing agreement with Celgene Cellular Therapeutics (“CCT”), a subsidiary of Celgene Corporation, whereby Alliqua received the right to develop and market Biovance. Under the licensing agreement, the field of use is for the management of non-infected partial- and full-thickness wounds, including chronic and acute wounds such as diabetic ulcers, pressure ulcers, venous ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/grafts, dehiscence), trauma wounds (abrasions, lacerations, second degree burns, and skin tears), and draining wounds.
On October 6, 2014, it was announced that the field of use for Biovance was expanded to include podiatric and orthopedic applications including sports medicine-related conditions pertaining to use during the repair of tendon, nerve and bone in the foot and ankle, as well as other surgical procedures in these specialty areas.
On November 3, 2014, Alliqua announced that Biovance was assigned a new Level II Healthcare Common Procedure Coding System (HCPCS) product reimbursement Q code (Q4154) by the Centers for Medicare and Medicaid Services. Biovance’s Q code assignment pertains to the Level II HCPCS coding system, and is used to identify products, supplies and services employed outside of a physician’s office, which are not included in the Level I HCPCS coding system. The new reimbursement code became effective on January 1, 2015.