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 end on December 31, 2020, if no action is taken by Congress.
At the Demonstration’s close, CMS has one year to assess its value and cost effectiveness and report to Congress its recommendation on whether to convert it to a permanent benefit. This means, those who have been receiving in-home IVIG services will not have access for at least one year while CMS conducts this study.
Project Still 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 advocating for an increase or elimination of this enrollment cap to allow more PI community members access to the benefit.
IDF Advocating for a Permanent Benefit
With coverage under the current Demonstration project scheduled to end on December 31, 2020, IDF is advocating for Congress to extend the demonstration for 2 years, raise the enrollment cap and ensure that CMS submits its report to Congress by October 2021, utilizing data from October 1, 2014 through September 30, 2020. This will ensure that individuals with PI are able to continue to receive IVIG at home while CMS conducts the study and Congress assesses the need for a permanent benefit. We are optimistic that the study will show the need for and value of home IVIG and will create a permanent benefit by October of 2022.
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.
Additional Information and Resources