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About the Medicare IVIG Access Demonstration Project

In 2003, Congress enacted the Medicare Modernization and Prescription Drug Act that includes a provision that allows Medicare to cover home infusion of intravenous immunoglobulin replacement therapy (IVIG) for primary immunodeficiency diseases (PI). The provision, however, only permits 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.

Many people with PI rely upon lifelong, lifesaving Ig replacement therapy to protect them from infections because they were born without a properly functioning immune system. Ig is a blood plasma product that helps prevent frequent and/or severe infections, and is administered through IVIG or subcutaneous immunoglobulin replacement therapy (SCIG). About 40% of people with PI who require Ig treatment receive IVIG. The option to use IVIG is individually determined by the patient and his/her physician, and involves considerations such as venous access, dosing schedules, adverse reactions and convenience of use based on their lifestyle.

To ensure that individuals with PI have access to all sites of care including the right to be infused in the home setting, the Immune Deficiency Foundation (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, creating a three-year demonstration project allowing for the payment of home infusion services for Medicare beneficiaries with PI.

Extension of the Medicare IVIG Demonstration Project

On September 28, 2017, Congress passed legislation extending the Medicare IVIG Demonstration through 2020, which was then signed into law by President Trump. This demonstration project is now set to run through December 31, 2020, or until allocated funds are spent, whichever comes first.

Project Accepting Applicants

The Centers for Medicare and Medicaid Services (CMS) continues to accept new demonstration project applicants on a rolling basis and will continue to do so until the demonstration reaches its statutory limit on enrollment and/or funding. IDF is also maintaining a dialogue with CMS and will keep the PI community up to date on information as it becomes available.

IDF Advocating for Permanent Benefit

IDF is pleased that individuals with PI who are in the demonstration project will continue to have their infusions covered while IDF advocates for Congress to make this a permanent benefit. In addition to urging that the demonstration project become a permanent benefit, IDF is advocating with CMS to include coverage for home IVIG under new regulations that were passed to implement a services payment for a variety of infused medications. Using this two pronged strategy, IDF is committed to ensuring that Medicare beneficiaries with PI have access to IVIG at home.

Need More Information about the Medicare IVIG Demonstration Project?

Check the CMS website to learn more about the Medicare IVIG Demonstration Project. Click here for more information.

Want to Show Support for the Medicare IVIG Demonstration Project?

Sign up for IDF Action Alerts! When your voice needs to be heard to support any future legislation regarding this project, we will notify you. Click here to sign up.

Additional Information and Resources

HR 1845 as Enacted

HR 1845 Summary

Video of Congressman Kevin Brady introducing HR 1845 on the House Floor on December 19, 2012

December 19, 2012 Congressional Record of the Floor Proceedings for HR 1845

ABC News Article on the Medicare IVIG Access Act – December 27, 2012

Immune Deficiency Foundation Press Release – January 2013

Medicare IVIG Demonstration Interim Report to Congress

Extension of Demonstration, Public Law No: 115-63

IDF Press Release – September 28, 2017