Coverage of Intravenous Immune Globulin for Treatment of Primary Immune

50.6 – Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home (Rev. 12352, Issued: 11-08-23, Effective: 01-01-24, Implementation: 01-02-24) The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provides coverage of intravenous immune globulin (IVIG) for the treatment of primary immune deficiency diseases in the home (ICD-10-CM codes G11.3, D80.0, D80.2, D80.3, D80.4, D80.5, D80.6, D80.7, D81.0, D81.1, D81.2, D81.5, D81.6, D81.7, D81.82, D81.89, D81.9, D82.0, D82.1, D82.4, D83.0, D83.1, D83.2, D83.8, or D83.9 if only an unspecified diagnosis is necessary). The Act defines “intravenous immune globulin” as an approved pooled plasma derivative for the treatment of primary immune deficiency disease. It is covered under this benefit when the patient has a diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patient’s home is medically appropriate. For coverage of IVIG under this benefit, it is not necessary for the derivative to be administered through a piece of durable medical equipment. Division FF, section 4134 of the Consolidated Appropriation Act, 2023 mandated that CMS establish a permanent, bundled payment for items and services related to administration of IVIG in a patient’s home. The permanent, bundled home IVIG items and services payment is effective for home IVIG infusions furnished on or after January 1, 2024. Payment for these items and services is required to be a separate bundled payment made to a durable medical equipment supplier for all items and services furnished in the home during a calendar day. It is up to the provider to determine the services and supplies that are appropriate and necessary to administer the IVIG for each individual. This may or may not include the use of a pump; however, a pump is not covered under the home IVIG items and services payment.