Criteria
Coverage is subject to the specific terms of the member's benefit plan.
| Preferred Agents | Non-Preferred Agents |
IM GAMASTAN (immune globulin G (IgG)/glycine) IVIG
BIVIGAM (human immunoglobulin gamma)
FLEBOGAMMA DIF (human immunoglobulin gamma)
GAMMAGARD S-D (human immunoglobulin gamma)
OCTAGAM (human immunoglobulin gamma)
PRIVIGEN (human immunoglobulin gamma)
GAMMAGARD LIQUID (human immunoglobulin gamma)
GAMMAKED (human immunoglobulin gamma)
GAMUNEX-C (human immunoglobulin gamma)
SCIG
HIZENTRA (human immunoglobulin gamma)
HYQVIA (human immune globulin G and hyaluronidase)
| IVIG ALYGLO (human immunoglobulin G - stwk) ASCENIV (human immune globulin G- slra) GAMMAPLEX (human immunoglobulin gamma) PANZYGA (immune globulin- ifas) SCIG CUTAQUIG (human immune globulin G - hipp) CUVITRU (human immunoglobulin gamma) XEMBIFY (immune globulin, gamma - klhw) |
Initial Criteria
Immune Globulin (IM, IV or SC) therapy may be considered medically necessary when the following criteria are met:
-
The use of the requested agent meets recommendations found in the Food and Drug Administration (FDA) labeling or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
-
If the individual's Body Mass Index (BMI) is greater than 30, adjusted body weight must be provided along with the calculated dose;
and
-
If the request is for a non-preferred agent, then one of the following:
-
The individual must have a documented trial and failure of each of the preferred products;
or
- The prescriber has provided documentation that the individual is stable on current therapy and has received the requested therapy in the past 45 days.
Reauthorization Criteria
Immune Globulin (IM, IV or SC) therapy may be considered medically necessary when the following criteria are met:
-
The individual has previously been approved for the requested agent through Blue Cross Blue Shield of North Dakota's precertification process;
and
- The prescriber has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy.
The use of immune globulin (IM, IV or SC) therapy not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
| 90283 | 90284 | J1459 | J1551 | J1554 | J1555 | J1556 |
| J1557 | J1558 | J1559 | J1561 | J1566 | J1568 | J1569 |
| J1572 | J1575 | J1576 |
