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BIVIGAM ORDERING INFORMATION

To place an order for BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] please see information below:

ADMA Biologics
Customer Operations
5800 Park of Commerce Blvd, NW
Boca Raton, FL 33487  

Toll free: 800-458-4244, option 1 

Email: CustomerService@admabio.com

BIVIGAM ORDERING INFORMATION

The information contained in this guide is provided for informational purposes only and is current as of April 2023. 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.

Download Coding Information
HCPCS Codea
HCPCS Code Description
J1556 Injection, Immune Globulin (BIVIGAM) Intravenous, Non-Lyophilized (e.g., Liquid), 500 mg

Home Infusion Therapy Codea
HCPCS Code Description
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

NDC Numbers
NDC Number to Use on All Claim Forms* Size Grams Protein Outer Package NDC Number Inner Package NDC Number
69800-6502-01 50 mL 5 69800-6502-1 69800-6502-2
69800-6503-01 100 mL 10 69800-6503-1 69800-6503-2
NDC Number to Use on All Claim Forms*
69800-6502-01
Size 50 mL
Grams Protein 5
Outer Package NDC Number 69800-6502-1
Inner Package NDC Number 69800-6502-2
69800-6503-01
Size 100 mL
Grams Protein 10
Outer Package NDC Number 69800-6503-1
Inner Package NDC Number 69800-6503-2

*For billing requiring an 11-digit NDC, add the preceding zero as shown above.

 


CPT® Codesb—IV Infusion
CPT Code Description
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: https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update;
https://www.cms.gov/files/zip/july-2023-alpha-numeric-hcpcs-file.zip.
bOptum® Current Procedural Coding Expert, publisher of CPT, a registered trademark of the AMA. Copyright 2022 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.

Indication

BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of patients with 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).

Important Safety Information for BIVIGAM®

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Use of immunoglobulin intravenous (IVIG) products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients at risk of acute renal failure include those with any degree of preexisting renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs.
  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction, or renal failure, administer BIVIGAM at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Contraindications

BIVIGAM is contraindicated in:

  • Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
  • IgA deficiency patients with antibodies to IgA and a history of hypersensitivity.

Warnings and Precautions

Thrombosis may occur following treatment with immune globulin (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 and ensure adequate hydration before administration. For patients at risk of thrombosis, administer BIVIGAM at the minimum dose and infusion rate practicable. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Severe hypersensitivity reactions may occur with IGIV products, including BIVIGAM. In case of hypersensitivity, discontinue BIVIGAM infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for treatment of acute hypersensitivity reactions. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Acute renal dysfunction/failure, osmotic nephrosis, and death may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering BIVIGAM. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of BIVIGAM and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuing BIVIGAM. In at-risk patients, administer BIVIGAM at the minimum infusion rate practicable.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV treatment, including BIVIGAM. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia. Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events.

Aseptic meningitis syndrome (AMS) may occur with IGIV treatments, including BIVIGAM. AMS usually begins within several hours to 2 days following IGIV treatment. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination on patients exhibiting signs and symptoms of AMS, including cerebrospinal fluid (CSF) studies, to rule out other causes of meningitis.

IGIV products, including BIVIGAM, may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Monitor patients for clinical signs and symptoms of hemolysis, including appropriate confirmatory laboratory testing.

Noncardiogenic pulmonary edema may occur in patients following IGIV treatment, including BIVIGAM. Transfusion-Related Acute Lung Injury (TRALI) is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours following treatment. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and the patient’s serum. TRALI may be managed using oxygen therapy with adequate ventilatory support.

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. All infections suspected by a physician to possibly have been transmitted by this product should be reported to ADMA Biologics at 1-800-458-4244.

After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test.

Adverse Reactions

Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject.

The most common adverse reactions to BIVIGAM (≥5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, increased blood pressure, 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.

The information on this site is intended for audiences in the United States only. The content on this site may not apply to non-US audiences as regulatory control, legal requirements, and/or medical practices may vary in other countries.

© 2023 ADMA Biologics, Inc. All rights reserved. BIVIGAM® is a registered trademark of ADMA Biologics, Inc. ADvantage Ig™ is a trademark of ADMA Biologics, Inc. PARTNER IN PROTECTION™ is a trademark of ADMA Biologics, Inc.