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The Medicare IVIG Demonstration (Demo) allows thousands of Medicare beneficiaries with primary immunodeficiency (PI) to receive life-saving IVIG in their home. This necessary and cost-effective option has proven invaluable to those with PI, and must be made a permanent benefit.  

About PI and IVIG

PIs are a group of more than 450 rare, chronic conditions in which part of the body’s immune system is missing or does not function correctly. PI can affect anyone, regardless of age, gender, or ethnicity. According to the National Institutes of Health, there are approximately 500,000 individuals in the U.S. with a PI. Every year, thousands go undiagnosed. Fortunately, many individuals with PI can live healthy productive lives if they receive lifelong immunoglobulin (Ig) replacement therapy. Ig is a blood plasma product that helps prevent frequent and severe infections and may be administered subcutaneously or intravenously. With approximately 4,000 Medicare beneficiaries with PI dependent on IVIG, it is essential that this small but vulnerable group have continued access to IVIG in the safety of their home. 

Medicare IVIG Access Background

In 2012, Congress passed the Medicare IVIG Access Act, which established a Demo that allowed enrollees with PI to receive IVIG at home by providing Part B reimbursement not just for the medication, but for the services and supplies required. The Demo began in 2014 and has been extended by Congress twice, in 2017 and 2020. Most recently, the Demo was extended through the end of 2023, capped at 6,500 enrollees, and a requirement was established that CMS provide a report to Congress on the outcomes of the demo by the end of 2022.  

Unless Congressional action is taken to establish permanent Medicare coverage for at-home IVIG, those who have been receiving such services will no longer have access to this benefit. As a result, the reported 3,394 beneficiaries enrolled in the Demo will only be able to receive these necessary treatments at facility-based sites. Such facilities are in short supply and, when they do exist, are challenging for those with PI given their compromised immune systems. Private insurers have demonstrated the cost-effectiveness of home-based care and frequently cover home infusions – this is a benefit that should be permanently available to Medicare beneficiaries as well.  

IVIG during the Coronavirus (COVID-19) Pandemic 

The current COVID-19 pandemic has demonstrated how essential it is for individuals with compromised immune systems to have the option of avoiding potentially dangerous environments by receiving treatments at home. Ensuring that those with PI have continuous access to at-home IVIG treatments during a health emergency and beyond is essential to the well-being of this community. The risk that all individuals are now facing due to COVID-19 is not a new phenomenon for the PI community – similar risks can exist for immunocompromised individuals during every facility-based infusion. 

Congressional Support 

The PI community urges Congress to support permanent Medicare coverage for home IVIG when legislation is introduced. Establishing this permanent benefit will ensure beneficiaries with PI have safe and consistent access to their essential and lifesaving treatments. 


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