ADMA Biologics Receives Unique Permanent J-Code for ASCENIV
RAMSEY, N.J. and BOCA RATON, Fla., Jan. 26, 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 issued a permanent, product-specific J-code for ASCENIV. Under the
Healthcare Common Procedure Coding System (HCPCS), the J-code (J1554) will become effective April 1, 2021 and will replace the currently issued C-code for ASCENIV (C9072), which can continue to be
utilized in the interim for reimbursement purposes. The Company will retain transitional pass-through status granted for ASCENIV from CMS.
“The issuance of this product-specific J-code by CMS for ASCENIV is a significant milestone in the product’s commercial launch. This J-code will provide for a streamlined and permanent reimbursement process in all outpatient treatment settings,” said Adam Grossman, President and Chief Executive Officer of ADMA. “The J-code implementation will accelerate and expand patient access to ASCENIV, and as a result, increases our confidence in the ongoing commercial roll-out, in addition to the product’s potential contribution to our overall 2024 revenue target of $250 million or more.”
Permanent J-codes are used by commercial insurers and government payers to standardize claims submissions and reimbursements for medications, such as ASCENIV, that are administered by a healthcare professional in an outpatient setting. While not a guarantee of payment, these codes enable timely claims adjudication and processing, and consequently facilitate a simplified pathway to prescription, administration and ultimately patient utilization.
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.