The information contained in this guide is provided for informational purposes only and is current as of September 2019. Providers are encouraged to contact their payers for specific information as coding rules and guidelines are subject to payer discretion and should be verified by the paying entity. It is the provider’s sole responsibility to determine and submit appropriate codes, charges, and modifiers for services rendered. The information provided in this guide is subject to change without notice.
Healthcare providers make the ultimate determination as to when to use a specific product based on clinical appropriateness for a patient. Third-party payment for medical products and services is affected by numerous factors, and ADMA Biologics cannot guarantee success in obtaining insurance payments.
|J1556||Injection, Immune Globulin (BIVIGAM) Intravenous, Non-Lyophilized (e.g., Liquid), 500 mg|
|S9338||Home infusion therapy, immunotherapy, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem|
|Outer Package NDC Number*||Size||Grams Protein||Inner Package NDC Number|
*Use the Outer Package 11-digit NDC number for billing purposes.
|96365||Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour|
|96366||Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (list separately in addition to code for primary procedure)|
For additional information please call 1-800-458-4244.
aCenters for Medicare and Medicaid Services (CMS). HCPCS file located at: http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html.
bOptum® Current Procedural Coding Expert, publisher of CPT, a registered trademark of the AMA. Copyright 2017 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.
BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] is indicated for the treatment of primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and history of hypersensitivity.
Thrombosis may occur following treatment with IGIV products, including BIVIGAM. Thrombosis may occur in the absence of known risk factors.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, administer BIVIGAM at the minimum dose and infusion rate practicable.
In patients at risk of developing acute renal failure, renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output need to be monitored.
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy. Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments; AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
As hemolysis can develop subsequent to treatment with IGIV products, monitor patients for hemolysis and hemolytic anemia. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). If TRALI is suspected, test the product and patient for antineutrophil antibodies.
Because BIVIGAM is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Passive transfer of antibodies with IGIV treatment may yield positive serological testing results, with the potential for misleading interpretation.
Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common adverse reactions to BIVIGAM (reported in ≥ 5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increase, diarrhea, dizziness, and lethargy.
You are encouraged to report side effects of prescription drugs to ADMA Biologics at 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
For more information about BIVIGAM, please see full Prescribing Information.