J1459, Injection, immune globulin (privigen), intravenous, non-lyophilized (e.g.,
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Documentation Required
- Claims should reference and be supported by LCD L34580 and follow the billing/coding guidelines in this article; specific documentation requirements (e.g., medical records, prior authorization) are those detailed in LCD L34580.
- Claims missing required NOC narrative information or with incorrect unit reporting will be rejected as unprocessable and may show remark code M123.
- All documentation must be maintained in the patient's medical record, be legible, include complete patient identification and dates of service, and be produced upon contractor request.
- Medical records must include the legible signature of the physician or non-physician practitioner responsible for the care.
- The submitted medical record must support the ICD-10-CM code(s), the CPT/HCPCS code(s) billed, and the medical necessity of services as stated in the applicable NCD and LCD.
- Records should include relevant diagnostic laboratory studies, prior history of bleeding or infection, disease progression, prior medical/surgical therapies, vaccination response, and any other information essential to establish that the patient meets NCD/LCD coverage indications.
Key Coverage Criteria
- Billing and coding for intravenous immunoglobulin (IVIG) should follow the Local Coverage Determination (LCD) L34580 and the billing/coding guidelines in this article as a complement to that LCD.
- Billing and coding guidance in this article applies when immune globulin use meets the reasonable and necessary coverage criteria established in LCD L35093.
- IVIG is covered only for indications specified as covered in the related Local Coverage Determination (LCD) and when medical necessity criteria in that LCD are met.
- Coverage requires documentation that the immune globulin therapy is reasonable and necessary in accordance with LCD L34007 and applicable NCDs.
- Off-label IVIG use may be billed when supported by the applicable Local Coverage Determination (LCD) and by documentation of medical necessity; off-label is defined as not in Medicare-approved compendia or the FDA label.
- IVIG may be used in bone marrow/stem cell transplantation when the recipient was CMV seropositive before transplantation, or after allogeneic transplantation for hematologic neoplasm when both donor and recipient were CMV seronegative.
20 Active Policies
CGS-L38268, Immune Thrombocytopenia (ITP) Therapy
J15
CGS-L35891, Intravenous Immune Globulin
J15
A57554, Billing and Coding: Immune Globulins
J5
A59105, Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG)
J6
WPS-L34771, Immune Globulins
J8
FIRST_COAST-L34007, Immune Globulin
J9
A57778, Billing and Coding: Immune Globulin
J9
NOVITAS-L35093, Immune Globulin
JH
PALMETTO-JJ-L34580, Intravenous Immunoglobulin (IVIG)
JJ
NGS-L39314, Off-Label Use of Intravenous Immune Globulin (IVIG)
JK
NGS-L40181, Off-Label Use of Intravenous Immune Globulin (IVIG)
JK
A56786, Billing and Coding: Immune Globulin
JL
PALMETTO-JM-L34580, Intravenous Immunoglobulin(IVIG)
JM
BCBSNM-ADM1001.034, Specialty Medication Administration Site of Care
BCBSOK-RX504.003, Immunoglobulin Therapy
BCBSOK-ADM1001.034, Specialty Medication Administration Site of Care
UMR-POL-UMR-immune-globulin-ivig-scig, Immune Globulin (IVIG and SCIG)
UMR-POL-UMR-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-immune-globulin-ivig-scig, Immune Globulin (IVIG and SCIG)
A56718, Billing and Coding: Intravenous Immunoglobulin (IVIG)
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.