ADMA Biologics Receives Unique Temporary C-Code and Pass-Through Payment Status for ASCENIV

RAMSEY, N.J. and BOCA RATON, Fla., Jan. 04, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through payment status and established a new reimbursement C-code, C9072, for ASCENIV which is effective January 1, 2021.

“Assignment of this new C-code by CMS for ASCENIV, along with pass-through payment status, will provide a more streamlined reimbursement process in the increasingly important hospital outpatient setting,” said Adam Grossman, President and Chief Executive Officer of ADMA. “This is another significant milestone in our ongoing commercial rollout of ASCENIV and is a testament to our market access and commercial teams’ continued execution. We believe our improving insurance coverage and expanding patient access for our commercial immunoglobulin portfolio is another indication that we remain well on track to achieve all of our previously provided operating targets by 2024, including generating revenues from all of our products of $250 million or greater.”

A C-code is a unique temporary product code established by CMS to help support Fee-for-Service pass-through payments in the Hospital Outpatient Prospective Payment System (OPPS). The formal implementation of the C-code will enable hospital outpatient departments to infuse ASCENIV in the outpatient setting and be reimbursed at the list price, also known as the Average Sales Price (ASP), for ASCENIV at +6%. Other payers, such as commercial insurers, may also use the C-code for billing purposes while awaiting a permanent J-Code, which ADMA expects will be assigned during 2021. Permanent J-codes can be used across all settings of care for government insurers and commercial payers to support timely claims submissions and receive standardized reimbursement rates.

About ASCENIV

ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.