ADMA Biologics Receives Unique Temporary C-Code and Pass-Through Payment Status for ASCENIV™
January 04 2021 - 8:00AM
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.
About ADMA Biologics,
Inc.
ADMA Biologics is an end-to-end American commercial
biopharmaceutical company dedicated to manufacturing, marketing and
developing specialty plasma-derived biologics for the treatment of
immunodeficient patients at risk for infection and others at risk
for certain infectious diseases. ADMA currently manufactures and
markets three United States Food and Drug Administration (FDA)
approved plasma-derived biologics for the treatment of immune
deficiencies and the prevention of certain infectious diseases:
BIVIGAM® (immune globulin intravenous, human) for the treatment of
primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin
intravenous, human – slra 10% liquid) for the treatment of PI; and
NABI-HB® (hepatitis B immune globulin, human) to provide enhanced
immunity against the hepatitis B virus. ADMA manufactures its
immune globulin products at its FDA-licensed plasma fractionation
and purification facility located in Boca Raton, Florida. Through
its ADMA BioCenters subsidiary, ADMA also operates as an
FDA-approved source plasma collector in the U.S., which provides a
portion of its blood plasma for the manufacture of its products.
ADMA’s mission is to manufacture, market and develop specialty
plasma-derived, human immune globulins targeted to niche patient
populations for the treatment and prevention of certain infectious
diseases and management of immune compromised patient populations
who suffer from an underlying immune deficiency, or who may be
immune compromised for other medical reasons. ADMA has received
U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and
10,259,865 related to certain aspects of its products and product
candidates. For more information, please visit
www.admabiologics.com.
Forward-Looking Statements
Any statements contained in this press release that
do not describe historical facts may constitute forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, including statements regarding the anticipated
benefits and expected consequences of the rights plan that ADMA has
adopted. Such statements are identified by use of the words
“anticipates,” “believes,” “estimates,” “expects,” “intends,”
“plans,” “predicts,” “projects,” “should,” and similar expressions.
Any forward-looking statements contained herein are based on
current expectations, but are subject to risks and uncertainties
that could cause actual results to differ materially from those
indicated, including, but not limited to, the effectiveness of the
rights plan in providing the Board of Directors with time to make
informed decisions that are in the best long-term interests of ADMA
and its stockholders, and other risk factors discussed from time to
time in our filings with the SEC, including those factors discussed
under the caption “Risk Factors” in our most recent annual report
on Form 10-K, filed with the SEC on March 13, 2020, and in
subsequent reports filed with or furnished to the SEC. ADMA assumes
no obligation and does not intend to update these forward-looking
statements, except as required by law, to reflect events or
circumstances occurring after today’s date.
COMPANY CONTACT:Skyler BloomDirector, Investor
Relations and Corporate Strategy | 201-478-5552 |
sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Sam MartinManaging
Director, Argot Partners | 212-600-1902 | sam@argotpartners.com
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