Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Subcutaneous Immune Globulin (SCIG) Therapy
Primary Immunodeficiencies
Subcutaneous Immune Globulin (Cutaquig, Cuvitru, Gammagard Liquid, Gammaked, Gamunex-C, Hizentra, HyQvia, or Xembify) may be considered medically necessary when ALL of the following criteria are met:
- Individual diagnosed with primary immunodeficiencies [e.g., congenital agammaglobulinemia, hypogammaglobulinemia, common variable immunodeficiency (CVID), severe combined immunodeficiency, Wiskott-Aldrich syndrome, or X-linked agammaglobulinemia (XLA)]; and
- Standard therapies have failed, become intolerable, or are contraindicated; and
- Laboratory evidence of immunoglobulin deficiency; and
- Persistent and severe infections despite treatment with prophylactic antibiotics; and
- Documented inability to mount an adequate immunologic response to inciting antigens; and
- Lack of appropriate rise in antibody titer following provocation with a polysaccharide antigen. For example, an adequate response to the pneumococcal vaccine may be defined as at least a four (4)-fold increase in titers for at least 50% of serotypes tested; or
- Lack of appropriate rise in antibody titer following provocation with a protein antigen. For example, an adequate response to tetanus/diphtheria vaccine may be defined as less than a four (4)-fold rise in titers three (3)-four (4) weeks after vaccine administration; and
- Other unspecified disorder of immune mechanism may be given individual consideration.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Subcutaneous Immune Globulin (Cutaquig, Cuvitru, Gammagard Liquid, Gammaked, Gamunex-C, Hizentra, HyQvia, or Xembify) may be considered medically necessary for individuals 18 years of age or older when ALL of the following criteria are met:
- Individual has confirmed diagnosis of CIDP; and
- Individual has demonstrated clinically meaningful response as indicated by documentation of stable or improved symptoms on intravenous immune globulin (IVIG) therapy.
The use of SCIG 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
| 90284 |
J1551 |
J1555 |
J1558 |
J1559 |
J1561 |
J1569 |
| J1575 |
