History of the Medicare IVIG Access Demonstration Project

In 2003, Congress enacted the Medicare Modernization and Prescription Drug Act, which included a provision that allows Medicare to cover home infusion of intravenous immunoglobulin replacement therapy (IVIG) for primary immunodeficiency (PI). The provision, however, only permitted reimbursement of the immunoglobulin (Ig) and not the supplies and other services necessary to administer the treatment—essentially making this a benefit on paper only.

IDF worked for years to have legislation passed that would allow Medicare beneficiaries with PI coverage for IVIG home infusions. In January 2013, the Medicare IVIG Access Act (HR 1845) become law, and in October 2014 the Centers for Medicare and Medicaid Services (CMS) began implementing the three-year demonstration project, allowing for the payment of home infusion supplies and services for 4,000 Medicare beneficiaries with PI.

The demonstration project has been extended twice, and the most recent extension pushed the enrollment cap to 6,500 individuals with PI. It also included a provision requiring that CMS report their findings on the effectiveness of the project by the end of 2022. This timing was intended to avoid a potential gap in coverage by giving time for Congress to analyze the findings and pass legislation for a permanent benefit before the demonstration expires at the end of 2023.

Thanks to the efforts of the PI community and IDF's advocacy team, a permanent Medicare benefit covering the medication, services, and supplies required for home IVIG therapy was passed on December 23, 2022. This permanent benefit will take effect on January 1, 2024, and provide coverage with no gap for all Medicare beneficiaries currently enrolled in the demonstration project. Medicare coverage for home IVIG infusion under the current demonstration project is scheduled to end at the end of 2023.