Attention Enrollees in the IVIG Demonstration

December 31, 2020

Medicare IVIG Demonstration Ends December 31, 2020

No payment will be made for demonstration services (supplies and related nursing services to administer IVIG in your home) provided after this date. The traditional Medicare fee-for-service program will continue to pay for IVIG, but when the demonstration ends, Medicare will no longer pay for the services and supplies to administer the drug in the home unless you are receiving covered Medicare home health services or you transition to other options for receiving IVIG, as further explained below.

There is not a new program to enroll in for continued coverage of IVIG administered in your home. We encourage you to discuss with your current supplier whether you can continue to receive IVIG in your home under the new Home Infusion Therapy program as further explained below. Only certain forms of immune globulin, certain methods of administration, and certain suppliers are allowed under the Home Infusion Therapy benefit.

Enrollees: Two Important Steps to Take Now

  1. Discuss the options for continuing to receive IVIG after December 31, 2020 with your healthcare professional who treats your immune disease and orders your IVIG treatment. You may be able to arrange to receive the IVIG in your doctor’s office or other outpatient setting. If medically appropriate, transition to a subcutaneous form of immune globulin that can be self-administered. In 2021, Medicare pays for professional services (nursing services) for certain forms of immune globulin, when administered through a pump in your home, under the Home Infusion Therapy benefit.
  2. Contact your Medicare supplier who currently provides your IVIG and related services to explain that the demonstration is ending and that you will need a new option for receiving IVIG and related services.

Suppliers: What You Need to Know and Resources

  • Claims for Q2052 billed with a Date of Service (DOS) after December 31, 2020 will be denied.
  • You have one year to file claims from the DOS to avoid a timely filing denial.
  • Noridian will stop enrollment in the demonstration as of November 16, 2020. For mailed applications, the post mark date must be on/before November 15 for us to process the IVIG application. Faxes received by 11:59 pm Central Time on November 15 will be accepted and the beneficiary enrolled, if eligible.
  • Suppliers will need to transition each beneficiary receiving IVIG through the demonstration to another method of receiving IVIG, as discussed in 1. above, for Medicare to consider payment for the administration of the IVIG and related services and supplies.
  • The only forms of immune globulin covered under the 2021 Home Infusion Therapy benefits are the following. These drugs must be provided subcutaneously using a pump.
    • J1555 JB Injection, immune globulin (cuvitru), 100 mg
    • J1558 JB Injection, immune globulin (xembify), 100 mg
    • J1561 JB Injection, immune globulin (gamunex-c/gammaked), non-lyophilized (e.g., liquid), 500 mg
    • J1562 JB Injection, immune globulin (vivaglobin), 100 mg
    • J1569 JB Injection, immune globulin (gammagard liquid), non-lyophilized (e.g., liquid), 500 mg
    • J1575 JB Injection, immune globulin/hyaluronidase, (hyqvia), 100 mg immune globulin
  • Suppliers wishing to continue to provide and bill for nursing services for 2021 need to enroll as a Medicare Part A or Part B provider.
  • For more information on the Home Infusion Therapy benefit, that is new for 2021, see https://www.cms.gov/files/document/mm11880.pdf and https://www.cms.gov/files/document/se19029.pdf.

Intravenous Immune Globulin (IVIG) Demonstration

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 demonstration started on October 1, 2014.

Background

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 link will take you to an external website.. This is a three year demonstration and may enroll no more than 4,000 Medicare beneficiaries. Under the demonstration there will be a per-visit payment amount for items and services needed for the in-home administration of IVIG.

Noridian Healthcare Solutions, LLC, the DME MAC for Jurisdiction A, is the Implementation Support Contractor for the IVIG Demonstration as of July 1, 2016.

Beneficiary Eligibility for Demonstration Participation

Applications for participation in the IVIG Demonstration will continue to be accepted on a rolling basis until Medicare reaches or projects it will reach the statutory limit on funding ($45 million including all costs for services, implementation and evaluation of the demonstration) and/or enrollment. The demonstration is scheduled to end December 31, 2020 (the last day to apply for coverage under this demonstation is November 15, 2020).

In order to enroll in the IVIG Demonstration, a beneficiary must:

  • Be covered under Medicare Fee-For-Service and enrolled in Part B,
  • Have a diagnosis of Primary Immune Deficiency Disease (PIDD), and
  • Not be currently covered under a home health episode of care.

Visit Information for Beneficiaries to access a copy of the IVIG Enrollment Application and instructions on how to properly complete and submit the form.

Providing and Billing for the In-Home Administration of IVIG

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 new demonstration covered services will be paid as a single bundle and will be subject to coinsurance and deductible as are other Part B services.

View Provider and Supplier for more information.

To ask IVIG questions or send information to Noridian, see the Contact Us webpage.

Last Updated Fri, 20 Oct 2017 09:56:38 +0000