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An Update on the Medicare IVIG Demonstration and the Legislation Attempting to Extend It

October 12, 2020

An Update on the Medicare IVIG Demonstration and the Legislation Attempting to Extend It

As we have shared, the Medicare IVIG Access Demonstration (demo) allowing Medicare beneficiaries with primary immunodeficiency (PI) to receive intravenous immunoglobulin replacement therapy (IVIG) in the home will end on Dec. 31, 2020 unless it is renewed by act of Congress.

In 2017, IDF was successful in ensuring congressional renewal of the demo that began serving patients in 2014, and is now working diligently to get the program renewed again. Presently, there is legislation, H.R. 7839, introduced in the House of Representatives which, when passed, will (1) extend the demo through 2022; (2) expand the enrollment cap; and (3) require Medicare to provide an evaluation of the first 6 years of the program. The program’s evaluation should support the need for a permanent benefit. With the support and advocacy of the PI community, IDF is striving to get this legislation incorporated into the package of bills that must pass by the end of the year.

Those in the PI community can contribute to IDF’s efforts to extend the demo by responding to the most recent IDF Action Alert to contact your elected representatives about this vital legislation. Additionally, signing up for Action Alerts will allow you to contribute to the ongoing advocacy efforts around this issue.

While IDF is optimistic that this legislation will pass, it is important that individuals in the PI community evaluate their personal treatment plan and prepare for the possibility of a lapse in the coverage provided by the demo project. We recommend investigating your Ig therapy options by consulting with your physician, specialty pharmacy, or infusion provider. Additionally, we recommend that demo enrollees review this Noridian article to help when considering future treatment possibilities.

It is essential that Medicare beneficiaries, who are currently enrolled in the demo, make a plan now to ensure that they continue to have access to Ig therapy in case H.R. 7839 does not pass before the end of the year. Consult with your treating physician to make that plan and consider the following options:

  1. Arrange to receive IVIG treatment in a doctor’s office, hospital, or other outpatient facility.
  2. Switch to subcutaneous immunoglobulin therapy (SCIG) if medically appropriate. SCIG can be self-administered with training provided by a nurse and in most cases, is covered by Medicare; and
  3. There may be options for home infusion as part of the rule flexibilities enacted by the Centers for Medicare and Medicaid during the COVID pandemic. Make sure to review the IDF blog post, Critical Update Now Allows Access to Home Infusions for Medicare Patients. This temporary measure means that some individuals with PI may qualify to receive IVIG at home through Medicare’s home health benefit. Please note, use of this option will depend both on the individual’s condition as to whether she/he meets the home health requirements that have been made more flexible; and the provider’s willingness to accept payment under these rules. In addition, without any further rule revisions, this option will be removed once there is no longer a public health emergency in place due to the pandemic. IDF cannot advocate for individual cases, rather, we encourage you to investigate options with your treating physician.

Please know that IDF is working tirelessly to renew the demo project and extend benefits for at-home IVIG for those in the PI community. We ask our community to remain on the lookout for ways you can help IDF with this mission, and to ensure you have a plan for your treatment in the months to come.

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