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 persons with Medicare enrolled in the demonstration as of November 15th, 2020 were automatically re-enrolled in the demonstration for the extension period and did not need to take any action. Suppliers continued to provide and be paid for demonstration services to those receiving care through the demonstration on or after January 1, 2021.
In accordance with the existing requirements of the demonstration, CMS continued to accept new enrollment into the demonstration.
The Medicare Intravenous Immune Globulin (IVIG) Demonstration was 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 IVIG demonstration ended on December 31, 2023. As of January 1, 2024, Section 4134 of the Consolidated Appropriations Act (CAA), 2023 made the IVIG in-home coverage permanent with no need for patients or eligible suppliers to enroll in the demonstration. For more information about IVIG coverage, please visit: https://www.cms.gov/medicare/payment/fee-for-service-providers/home-infusion-therapy
Background
The Medicare IVIG Demonstration was 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 persons with Medicare can participate in the demonstration, an increase from the initial 4,000 eligible persons with Medicare as instructed in the original legislation.
Under the demonstration, there was 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 was updated each calendar year.
Initiative Details
Under this demonstration, Medicare provided a bundled payment under Part B for items and services that were necessary to administer IVIG in the home to enrolled persons with Medicare who were not otherwise homebound and receiving home health care benefits. The demonstration only applied to situations where persons with Medicare required intravenous immune globulin for the treatment of PIDD or was currently receiving subcutaneous immune globulin to treat PIDD and wished to switch to intravenous immune globulin.
To participate in this demonstration, persons with Medicare had to complete and submit an application form. The person with Medicare as well as his or her physician had to sign all applications. The persons with Medicare had to 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 required IVIG for the treatment of PIDD. Since the number of participants and funding for the demonstration were limited under the law, submission of an application did not guarantee that a person with Medicare would be accepted to participate in the demonstration.
Services covered under the demonstration were provided and billed by the specialty pharmacies that provided the immune globulin drug, which is already covered under Medicare Part B. The demonstration covered services were paid as a single bundle and were subject to coinsurance and deductible in the same manner as other Part B services. Home health agencies were not eligible to bill for services covered under the demonstration but could still bill for services related to the administration of IVIG that are covered under the payment for a home health episode of care.
Evaluations
Latest Evaluation Reports
Prior Evaluation Reports
- Medicare IVIG Demonstration - Updated Interim Report to Congress (PDF)
- Medicare IVIG Demonstration - Interim Report to Congress (PDF)
Additional Information
- Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012 [P.L. 112-242] (PDF)
- Open Door Forum: Discussion of the Medicare Intravenous Immune Globulin (IVIG) Demonstration | Slides (PDF)
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