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About the Medicare IVIG Access Demonstration Project

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

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, 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 services for Medicare beneficiaries with PI.

Extensions of the Medicare IVIG Demonstration Project

In September of 2017, Congress passed and the president signed into law legislation extending the Medicare IVIG Demonstration through December 31, 2020.

Near the end of December 2020, legislation was enacted to ensure individuals enrolled in the Medicare IVIG Demonstration could continue to receive their immunoglobulin (Ig) therapy at home without disruption through 2023. The legislation included provisions extending the demonstration for three years and expanding the cap on enrollment from 4000 to 6500 individuals, allowing additional Medicare beneficiaries with PI to enroll in the project. It also included a provision requiring that CMS report their findings on the effectiveness of the project by the end of 2022. This helps 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 in 2023.

IDF Advocating for a Permanent Benefit

With coverage under the current Demonstration project scheduled to conclude at the end of 2023, the IDF advocacy team continues to work on ensuring that a permanent benefit is created to cover the medication, services, and supplies required for home IVIG therapy. As has been highlighted during the COVID-19 pandemic, it is essential that individuals who are immunocompromised, especially those with primary immunodeficiencies, have an option to receive infusions 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?

Take part in IDF Virtual Advocacy Day 2020 on April 23 to reach out to your elected representatives urging them to make the Medicare IVIG Demonstration a permanent benefit.

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

Medicare IVIG Demonstration Handout, IDF Virtual Advocacy Day 2020

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

IDF Letter to CMS Regarding Home Health Rule, Dated 8.23.18

IDF Letter to CMS Regarding Home Health Rule, Dated  8.28.19

IDF Letter to CMS Regarding Home Health Rule, Dated 12.17.19