On Sunday, December 27th, 2020 the President signed legislation that extended the Medicare IVIG Demonstration through December 31, 2023. Previously, the demonstration had been scheduled to end December 31, 2020.
All beneficiaries enrolled in the demonstration as of November 15th, 2020 will automatically be re-enrolled in the demonstration for the extension period and do not need to take any action. Suppliers can continue to provide and be paid for demonstration services to these beneficiaries on or after January 1, 2021.
In accordance with the existing requirements of the demonstration, CMS is continuing to accept new enrollment into the demonstration. Please check the demonstration website for more information regarding new applications.
The Medicare Intravenous Immune Globulin (IVIG) Demonstration is being implemented to evaluate the benefits of providing payment and items for services needed for the in-home administration of intravenous immune globulin for the treatment of primary immune deficiency disease (PIDD).
The Medicare IVIG Demonstration is authorized under Title I, section 101 of the “Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012 (P.L. 112-242)”. This legislation authorized a three-year demonstration under Part B of Title XVIII of the Social Security Act to evaluate the benefits of providing payment for items and services needed for the in-home administration of IVIG for the treatment of PIDD.
On September 28, 2017, Congress passed the ‘‘Disaster Tax Relief and Airport and Airway Extension Act of 2017.’’ Title III, section 302 of that act extended the Medicare IVIG Demonstration through December 31, 2020.
On December 21, 2020, Congress again extended the demonstration for three additional years under the "Consolidated Appropriations Act, 2021." The legislation also instructs that 6,500 eligible beneficiaries can participate in the demonstration, an increase from the initial 4,000 eligible beneficiaries as instructed in the original legislation.
Under the demonstration, there is a per-visit payment amount for items and services needed for the in-home administration of IVIG based on the national per visit low-utilization payment amount (LUPA) under the prospective payment system for home health services. The payment amount is updated each calendar year.
Under this demonstration, Medicare provides a bundled payment under Part B for items and services that are necessary to administer IVIG in the home to enrolled beneficiaries who are not otherwise homebound and receiving home health care benefits. The demonstration only applies to situations where the beneficiary requires intravenous immune globulin for the treatment of PIDD, or is currently receiving subcutaneous immune globulin to treat PIDD and wishes to switch to intravenous immune globulin.
In order to participate in this demonstration, beneficiaries must complete and submit an application form. The beneficiary as well as his or her physician must sign all applications. Beneficiaries must meet specified eligibility requirements including being covered under the original Medicare fee-for-service program and not enrolled in a Medicare Advantage plan, have Part B, and require IVIG for the treatment of PIDD. Since the number of participants and funding for the demonstration are limited under the law, submission of an application does not guarantee that a beneficiary will be accepted to participate in the demonstration.
Services covered under the demonstration shall be provided and billed by the specialty pharmacies that provide the immune globulin drug, which is already covered under Medicare Part B. The demonstration covered services are paid as a single bundle and are subject to coinsurance and deductible in the same manner as other Part B services. Home health agencies are not eligible to bill for services covered under the demonstration but may still bill for services related to the administration of IVIG that are covered under the payment for a home health episode of care.
To receive the latest news and updates about the Intravenous Immune Globulin Demonstration, subscribe to the Intravenous Immune Globulin Demonstration listserv.
To obtain additional educational materials and information on how to apply to participate in this demonstration, please visit the Noridian implementation support contractor website or call (844)-625-6284.
How to Apply
The initial enrollment period concluded on November 15, 2020. However, under the most recent extension, new applications for participation in the IVIG Demonstration are being accepted on a rolling basis until the demonstration reaches or is projected to reach the statutory limit on funding and/or enrollment. Beneficiaries will be notified within 10 calendar days of receipt of a complete application of their status and the effective date of their coverage under the demonstration. Completed applications received by the 15th of the month, if eligible, will have coverage effective the 1st of the following month. Completed applications received after the 15th of the month, if eligible, will have coverage effective the 15th of the following month. For example, if an application is received on September 15th, coverage will be effective October 1st. If an application is received on September 20th, coverage will be effective October 15th.
- Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012 [P.L. 112-242] (PDF)
- Fact Sheet (PDF) (updated 10/24/17)
- Medicare IVIG Demonstration - Interim Report to Congress (PDF)
- Beneficiary Frequently Asked Questions (updated 06/24/16)
- Supplier Frequently Asked Questions (updated 06/24/16)
- Medicare IVIG Demonstration Beneficiary Flyer (PDF)
- Application and additional educational information
- Open Door Forum: Discussion of the Medicare Intravenous Immune Globulin (IVIG) Demonstration | Slides (PDF)
- Subscribe to the Intravenous Immune Globulin (IVIG) Demonstration listserv