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Posted on 14. October 2021

Medicare IVIG Demonstration Project

By Abbie Cornett

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As the patient advocate for IG Living, I am frequently asked for information about the Medicare IVIG Demonstration Project and its purpose. The Centers for Medicare and Medicaid Services (CMS) conducts and sponsors demonstration projects to test and measure the effect of potential program changes on patients and their access to treatment. Projects study the likely impact of new methods of service delivery, coverage of new types of service and new payment approaches on beneficiaries, providers, health plans, states and the Medicare Trust Funds.1

The Medicare IVIG Demonstration Project was implemented to evaluate the benefits of providing payment and items for services needed for the in-home administration of intravenous immune globulin (IVIG) for the treatment of primary immune deficiency disease (PI)2. The project, which has been in effect since October 2014, was slated to end Dec. 31, 2020, but it was extended by Congress through Dec. 31, 2023. The original intent of the project was to determine if adding payment for supplies and services for nursing would improve access to home infusion therapy for patients with specific primary immune deficiency diagnoses receiving IVIG.

For patients to be eligible for the demonstration project, they must be covered by traditional fee-for-service Medicare Part B and be actively enrolled in Part B. So, enrollment doesn't apply to someone who has a Medicare Advantage plan. The beneficiary also needs to be receiving IVIG for one of the diagnosis codes currently covered by Medicare Part B in the home setting, which includes some but not all of the PI diagnosis codes. Twenty-four diagnosis codes are covered under Medicare Part B for home infusion.

Further, if a patient is receiving other home health services such as a home health aide for diabetic medication or another home health episode of care, there isn't coverage for the demonstration project until that episode of home healthcare has ended. Therefore, individuals can apply to be a part of the demonstration project if they're not under another home health episode of care that can be billed to Medicare Part B.

It is important to understand that the extension of the program calls for a report of the services to be evaluated and submitted in 2022. If the report shows the project has accomplished its original goals, perhaps we'll see a long-term permanent coverage for supplies and services in the home for all beneficiaries receiving IVIG rather than just the demonstration project beneficiaries.

For further information about the demonstration project and other changes in Medicare that can affect patients who are treated with IG, listen to my latest podcast that can be found at www.igliving.com/life-with-ig/podcast-episodes/E04-Changes-in-Medicare-That-Affect-Patients-Treated-with-Immune-Globulin.html.


1  CMS.gov. Medicare Demonstration Projects & Evaluations Reports. Accessed at www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts
2  CMS.gov. Medicare Intravenous Immune Globulin (IVIG) Demonstration. Accessed at innovation.cms.gov/innovation-models/ivig.


Comments (1) -

Lynn Albizo
8:13 AM on Monday, October 18, 2021

The Immune Deficiency Foundation has advocated for this demonstration since it's inception. We are working now ensure that this benefit will become permanent. We are optimistic that the report will show that home infusion is effective and cost efficient. Once the report is completed, Congress will still need to act to make this a permanent Medicare benefit and advocacy will be needed by all stakeholders. -Lynn Albizo, Vice President to Public Policy, Immune Deficiency Foundation

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