Medicare Intravenous Immune Globulin (IVIG) Demonstration: Beneficiary Frequently Asked Questions

1) What is the Medicare IVIG Demonstration?

The "Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012" 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 Primary Immune Deficiency Disease (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. Congress again had extended the demonstration on December 21, 2020 for three additional years under the "Consolidated Appropriations Act, 2021," Division CC, Section 104, Extension of Medicare Patient IVIG Access Demonstration Project. For more information about the demonstration, please visit the CMS Medicare IVIG Demonstration web page.

2) Is this already a Medicare benefit or a new benefit under Medicare?

No. This is a not a regular or a new Medicare benefit. It is a special demonstration. Both the number of beneficiaries as well as the duration of the demonstration is limited by law. In order to participate in this demonstration, a beneficiary must complete and submit a special demonstration application. Submission of an application is not a guarantee that a beneficiary will be selected to participate in the demonstration.

3) Why is Medicare doing the IVIG Demonstration?

This demonstration was mandated by Congress under the “Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012.”

4) What exactly is covered under the Medicare IVIG Demonstration?

Currently, Medicare pays for IVIG medications for beneficiaries who have primary immune deficiency who wish to receive the drug at home. However, the traditional Medicare fee for service benefit does not currently cover any services to administer the drug to a beneficiary at home such as nursing services and certain supplies. Under the demonstration, Medicare will pay a bundled payment for the administration and supplies related to the administration of IVIG for beneficiaries who are otherwise eligible to receive IVIG in the home. Medicare Part B coinsurance and deductibles will apply to services covered under the demonstration as they do to other Part B services (e.g. if the drug is administered in a doctor's office).

5) Who is eligible for the Medicare IVIG Demonstration?

In order to be eligible to participate in this demonstration, a Medicare beneficiary must be enrolled in Part B and covered under the traditional Medicare fee-for-service program (i.e. not enrolled in a Medicare Advantage plan). In addition, the beneficiary must need the IVIG to treat Primary Immune Deficiency Disease (PIDD). Beneficiaries who are covered under a home health episode of care are not eligible to have services covered under the demonstration because those services are already covered under the Medicare home health benefit.

6) What are the medical conditions that qualify for the Medicare IVIG Demonstration?

The medical condition that qualifies for coverage under the Medicare IVIG Demonstration is Primary Immune Deficiency Disease (PIDD).

7) When does this demonstration start?

This demonstration started on October 10, 2014. Applications will be accepted on a space available basis. For the most current information, please visit the CMS Medicare IVIG Demonstration web page. 

8) How will I learn more details about the IVIG Demonstration?

Please continue to review the CMS Medicare IVIG Demonstration web page for the most up to date information. Interested parties may also wish to join the CMS Intravenous Immune Globulin (IVIG) Demonstration listserv to be alerted whenever updated information is added to this site. 

9) Do I have to enroll in this demonstration if I currently receive my primary immune deficiency treatment intravenously?

No, participation in this demonstration is voluntary. However, you must be enrolled in the demonstration if you do wish to participate.

10) Can I enroll if I receive my primary immune deficiency treatment subcutaneously?

This demonstration provides services to administer immunoglobulin intravenously. However, if you will be changing your method of receiving your medication from subcutaneously to intravenously (IV), you may apply to participate. If you want to continue to receive your medication subcutaneously, you are not eligible for this demonstration.

11) I get my primary immune deficiency treatment intravenously at my doctor’s office. Do I have to enroll in the Medicare Intravenous Immune Globulin Demonstration?

No. This is a voluntary demonstration. If you choose not to participate, you may continue to receive intravenous immune globulin in your doctor's office, under the current Medicare benefit, as you do now. If you would like to begin receiving intravenous immune globulin in your home, you should talk with your doctor to determine whether participation in this demonstration would be a good idea for you. Please note that if you do wish to participate in this demonstration, you must submit an application that is signed by both you and your doctor.

12) I get my primary immune deficiency treatment intravenously at my local hospital outpatient department. Do I have to enroll in the Medicare Intravenous Immune Globulin Demonstration?

No. This is a voluntary demonstration. If you choose not to participate, you will continue to receive intravenous immune globulin at your local hospital outpatient department, under the current Medicare benefit, as you do now. If you would like to begin receiving intravenous immune globulin in your home, talk with your doctor to determine whether participation in this demonstration would be a good idea for you. Please note that if you do wish to participate in this demonstration, you must submit an application that is signed by both you and your doctor.

13) How do I enroll?

The application window has closed. Further updates to come.

14) Is there a deadline for submitting applications?

Applications will be accepted and reviewed on a rolling basis until all slots have been filled. Because of the eligibility requirements and the limitation on the number of beneficiaries that can participate, submission of an application does not guarantee that you will be selected to participate in the demonstration.

15) How soon after I submit my application will I hear if I have been accepted?

Beneficiaries who submitted a complete application form will be notified within 12 business days whether or not they have been accepted.

16) Will everyone who enrolls get accepted?

No. Since the number of participants and funding for the demonstration are limited under the law, submission of an application does not guarantee that all beneficiaries that meet the above specified eligibility requirements will be accepted to participate in the demonstration.

17) Does my doctor have to do anything to get me enrolled in this demonstration?

Yes. It is important that you discuss with your physician whether participation in this demonstration is appropriate for you. Therefore, your physician will have to complete and sign the last portion of your application form. Incomplete applications will be returned and will not be considered.

18) Where can I find out more information?

You can call the Medicare Intravenous Immune Globulin Demonstration Hot Line at (844)-625-6284 for help with your questions.

19) How long will this demonstration last?

The Medicare Intravenous Immune Globulin Demonstration is authorized until December 31, 2023, contingent on availability of funds or if the enrollment capacity has been reached.

20) Do I have to stay in the Medicare Intravenous Immune Globulin Demonstration for the whole time? What if I don’t want to?

You do not have to stay in the Medicare Intravenous Immune Globulin Demonstration for the entire three years, and can withdraw from the demonstration at any time without affecting your Medicare benefits.

21) How will my claims get paid?

Only Medicare pharmacy suppliers that provide and bill for both the medication and the services to administer it will be eligible for payment under this demonstration.

The Medicare supplier who provides the medication and the administration will submit the claims to the Durable Medical Equipment Medicare Administrative Contractor (DME MAC).

If your Medicare supplier who provides the medication and the administration has general questions about this demonstration, they can also call the Medicare Intravenous Immune Globulin Demonstration Hot Line at (844)-625-6284.

Once the demonstration is implemented, suppliers who have claims related questions can contact their local DME MAC:

Jurisdiction A: https://med.noridianmedicare.com/web/jadme
Jurisdiction B: http://www.cgsmedicare.com/
Jurisdiction C: http://www.cgsmedicare.com/
Jurisdiction D: http://med.noridianmedicare.com/web/jddme

22) Will my current Medicare benefits be affected if I decide not to submit an application to enroll in the demonstration?

No. Participation in the demonstration is voluntary and will not affect your current Medicare benefits or entitlement.
 

23) Have you been approved for the IVIG Demonstration? The next step is to find a Supplier by following one of the steps below.

Tell your doctor that you've been approved for the IVIG Demonstration. Your doctor will give you a prescription for your IVIG treatment in the home from a specialty pharmacy. If your doctor arranges your services from a specialty pharmacy, have your doctor tell the specialty pharmacy that you've been approved for the IVIG Demonstration.

Alternatively,  use the the Medicare.gov website to find specialty pharmacies in your area:

1. From http://medicare.gov, scroll down to the bottom of the page and look for the heading "Take Action".
2. Select the link titled “Find medical equipment & suppliers”.
3. A new screen will appear where you can enter your ZIP code.
4. In the Equipment box enter infusion.
5. Select the Search button.
6. A list of choices will appear. Select the box for Infusion Pumps not insulin and select Update.
7. A list of suppliers within 10 miles will appear.
8. To increase your search to a wider area, select the drop down arrow in the distance box and choose a selection and Apply.

Contact the specialty pharmacy of your choice and tell them that you’ve been approved for the Medicare IVIG Demonstration. Show them your approval letter so they will know they can submit claims for the demonstration services.

The specialty pharmacy will bill Medicare for your IVIG drugs and will bill Medicare for the per-visit payment for nursing and supplies needed to administer the IVIG. You will be responsible for paying any applicable Medicare Part B deductible or coinsurance.