J1561 — Injection, immune globulin, (gamunex-c/gammaked), non-lyophilized (e.g., liquid), 500 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
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.
- The medical record must include the ordering provider's assessment related to the complaint, relevant medical history, results of pertinent tests/procedures, and signed and dated office visit or operative reports.
- Required documentation of medical necessity includes history and physical, a supporting physician rationale current within the last 12 months, and physician orders not more than 30 days old specifying dose, frequency, administration route and duration, with office/progress notes documenting necessity for initiation and continuation.
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.
- IVIG is covered for patients with common variable immunodeficiency (CVID) when initial presenting IgG levels, evidence of Pneumovax vaccination, and pre- and post-vaccine pneumococcal antibody titers demonstrate inability to produce an antibody response to protein or carbohydrate antigens, and documentation includes dual diagnoses and a statement of lack of response to protein antigen.
- IVIG is covered for patients with HIV disease and immune thrombocytopenic purpura (ITP) when the medical record documents a platelet count less than 30,000 and active bleeding supported by laboratory results.
- IVIG is covered for immunodeficient individuals with recurrent or chronic bacterial sinusitis when the record documents findings diagnostic of or highly suggestive of bacterial sinus infection (for example fever, unilateral purulent nasal discharge, unilateral facial pain) and documents prolonged and/or recurrent antibiotic therapy.
- IVIG is covered for stiff-man syndrome when the patient is under the care of a physician competent in diagnosis, meets the defined diagnostic criteria, has failed conservative therapy (e.g., benzodiazepines), and documentation shows objective response after initial treatment for continued coverage.
- IVIG is covered when the treating physician documents medical necessity for initiation or continuation, including history and physical, a current supporting physician rationale (within 12 months), and physician orders (<=30 days old) specifying dose, frequency, administration route and duration with office/progress notes documenting response.
19 Active Policies
L34771 — Immune Globulins
J05
A57554 — Billing and Coding: Immune Globulins
J05
A60187 — Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG)
J06
L40181 — Off-Label Use of Intravenous Immune Globulin (IVIG)
J06
L39314 — Off-Label Use of Intravenous Immune Globulin (IVIG)
Related Codes
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