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Information for Beneficiaries - IVIG

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 qualifications needed and how to enroll, see https://www.cms.gov/files/document/mm11954.pdf.
  • 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.

Information for Beneficiaries

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 and/or enrollment (4,000 beneficiaries). At this time, applications are still being received.

Please note that in order to be enrolled 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.

IVIG Demonstration Enrollment Application

All beneficiaries must complete and submit a signed application in order to be considered for this demonstration. The blank application may be printed and completed manually or filled in online and printed before signing. Once completed and signed by the beneficiary, the application must also be signed by the beneficiary's treating physician:

Your version of Adobe Acrobat may offer a feature to "digitally sign" the application document. Users should not use this feature as it does not properly qualify as a signature. Once completed, the application must be printed and signed with an ink pen.

IVIG Demonstration Enrollment Application Guide

These guides provide complete instructions for completing the IVIG Demonstration Enrollment Application.

Submitting the Application

By Fax - Completed IVIG Demonstration applications can be faxed to: 701-277-2428.

By Mail - Completed IVIG Demonstration applications can be mailed to:
Noridian Healthcare Solutions
IVIG Demo
PO Box 6788
Fargo  ND 58108-6788

Overnight Mailing
Noridian Healthcare Solutions
IVIG Demo
900 42nd St S
Fargo ND 58103

Notification Process

All IVIG Demonstration applicants will be notified within ten business days of receipt of a complete application of their status and the effective date of their coverage under the demonstration.

Effective Dates for Enrollment

Completed applications received by the 15th of the month, if eligible, will have coverage effective the first of the next month.

Completed applications received after the 15th of the month, if eligible, will have coverage effective the fifteenth of the next month. For example, if an application is received on September 15, coverage will be effective October 1. If an application is received on September 20, coverage will be effective October 15.

Last Updated Mon, 20 Apr 2020 15:56:00 +0000