Gammagard Liquid® (J1569) Added as Covered Subcutaneous Immune Globulin

Posted August 26, 2011

Gammagard Liquid® (J1569) is added to the External Infusion Pump LCD as covered subcutaneous immune globulin effective for dates of service on or after July 22, 2011.

The existing HCPCS code for Gammagard Liquid® must be used:

J1569 - INJECTION, IMMUNE GLOBULIN, (GAMMAGARD LIQUID), INTRAVENOUS, NONLYOPHILIZED, (E.G. LIQUID), 500 MG

For J1569 and associated infusion pump (E0779) claims where the route of administration is subcutaneous, a JB modifier must be added to each HCPCS code. For other methods of administration, no modifier should be added.

One (1) unit of service (UOS) is 500mg. Gammagard liquid is distributed in multiple package sizes from one (1)-gram (1000mg) to thirty (30)-grams (30,000mg). Suppliers must choose the package size that is appropriate for the dosage being administered to minimize waste. For example,

1500mg is prescribed (3 UOS). Gammagard liquid is available in 1-gram (2UOS) and 2.5-gram (5 UOS) sizes. Two 1-gram vials (4 UOS) must be used rather than one 2.5-gram vial (5 UOS).

Excess wastage due to non-optimal vial sizes will be denied as not reasonable and necessary.

As a reminder, below are the coverage criteria from the External Infusion Pump LCD:

"Subcutaneous immune globulin (J1559, J1561, J1562) is covered only if criteria 1 and 2 are met:

1. The subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and

2. The patient has a diagnosis of primary immune deficiency disease (ICD-9 codes 279.04, 279.05, 279.06, 279.12, 279.2).

Coverage of subcutaneous immune globulin applies only to those products that are specifically labeled as subcutaneous administration products. Intravenous immune globulin products are not covered under this LCD.

Only an E0779 infusion pump is covered for the administration of subcutaneous immune globulin. If a different pump is used, it will be denied as not reasonable and necessary."

Gammagard Liquid will be added in a future revision of the LCD.

Refer to the LCD, Policy Article and Supplier Manual for additional information.

            Last Updated Fri, 26 May 2017 13:21:40 +0000