FAQs - English - IVIG

Q1. What is the Medicare Intravenous Immune Globulin (IVIG) Demonstration?
A1. The "Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012" established a three year demonstration to evaluate the benefits of providing payment for items and services needed for the in-home administration of intravenous immune globulin (IVIG) for the treatment of Primary Immune Deficiency Disease (PIDD). Since then the demonstration has been extended per legislation and currently is scheduled to end on December 31, 2023 or when enrollment and spending limits are met. For more information about the demonstration, please see the CMS demonstration website at https://www.cms.gov/priorities/innovation/innovation-models/ivig

In addition, please visit the IVIG Demonstration website.

Q2. Is this already a Medicare benefit or a new benefit under Medicare?
A2. No. This is a not a regular or a new Medicare benefit. It is a special demonstration. Both the number of beneficiaries, money paid for demonstration services and administration of the program, as well as the duration of the demonstration are 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.

Q3. Why is Medicare doing the IVIG Demonstration?
A3. This demonstration was mandated by Congress under the "Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012."

Q4. What exactly is covered under the Medicare IVIG Demonstration?
A4. 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).

Q5. Who is eligible for the Medicare IVIG Demonstration?
A5. 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.

Q6. What are the medical conditions that qualify for the Medicare IVIG Demonstration?
A6. The medical condition that qualifies for coverage under the Medicare IVIG Demonstration is Primary Immune Deficiency Disease (PIDD).

Q7. When did this demonstration start?
A7. The demonstration started on 10/01/2014. Applications will be accepted on a space available basis. For the most current information, please see the CMS Demonstration website: https://www.cms.gov/priorities/innovation/innovation-models/ivig. In addition, please visit the IVIG Demonstration website.

Q8. How will I learn more details about the IVIG Demonstration?
A8. Please continue to review the website at: https://www.cms.gov/priorities/innovation/innovation-models/ivig for the most up to date information.

In addition, please visit the IVIG Demonstration website.

Q9. Do I have to enroll in this demonstration if I currently receive my primary immune deficiency treatment intravenously?
A9. No. Participation in this demonstration is voluntary. However, you must be enrolled in the demonstration if you do wish to participate.

Q10. Can I enroll if I receive my primary immune deficiency treatment subcutaneously?
A10. 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.

Q11. I get my primary immune deficiency treatment intravenously at my doctor's office. Do I have to enroll in the Medicare IVIG Demonstration?
A11. No. This is a voluntary demonstration. If you choose not to participate, you may continue to receive IVIG in your doctor's office, under the current Medicare benefit, as you do now. If you would like to begin receiving IVIG 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.

Q12. I get my primary immune deficiency treatment intravenously at my local hospital outpatient department. Do I have to enroll in the Medicare IVIG Demonstration?
A12. No. This is a voluntary demonstration. If you choose not to participate, you will continue to receive IVIG at your local hospital outpatient department, under the current Medicare benefit, as you do now. If you would like to begin receiving IVIG 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.

Q13. How do I enroll?
A13. Beneficiaries interested in participating in this demonstration must submit an application. 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.

Applications are available:

• On the "Information for Beneficiaries" webpage of Noridian IVIG website, http://med.noridianmedicare.com/web/ivig/beneficiaries
• Through the Medicare IVIG Contact Center: Call 844-625-6284

Completed applications may be mailed to:

Noridian Healthcare Solutions
IVIG Demo
PO Box 6788
Fargo ND 58108-6788

For overnight mailings:

Noridian Healthcare Solutions
IVIG Demo
4510 13th Ave S Suite 1
Fargo ND 58103-6646

Or fax your application to: 701-277-2428

Q14. Is there a deadline for submitting applications?
A14. 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. The demonstration ends December 31, 2023. To be eligible for any coverage before the demonstration ends, applications must be received by November 15, 2023.

Q15. How soon after I enroll will I hear if I have been accepted?
A15. Beneficiaries who submitted a complete application form will be notified within 12 business days whether or not they have been accepted.

Q16. Will everyone who submits an application get accepted?
A16. 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.

Q17. Does my doctor have to do anything to get me enrolled in this demonstration?
A17. Yes. It is important that you discuss with your physician whether participation in this demonstration is appropriate for you. 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.

Q18. Where can I find out more information?
A18. You can visit http://med.noridianmedicare.com/web/ivig. The Medicare IVIG Demonstration webpage has helpful information such as:

• An application form
• A "Guide" to help you complete the enrollment application
• Helpful links to other websites

You can also call the Medicare IVIG Contact Center at 844-625-6284 for help with your questions.

Q19. How long will this demonstration last?
A19. The Medicare IVIG Demonstration is authorized for three years, until December 31, 2023, contingent on availability of funds.

Q20. Do I have to stay in the Medicare IVIG Demonstration for the whole time? What if I don't want to?
A20. You do not have to stay in the Medicare IVIG Demonstration for the entire time and can withdraw from the demonstration at any time without affecting your Medicare benefits.

Q21. How will my claims get paid?
A21. 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 IVIG Demonstration Contact Center at 844-625-6284.

Suppliers who have claims related questions can contact their local DME MAC:

• Jurisdiction A: http://med.noridianmedicare.com/web/jadme
• Jurisdiction B: http://www.cgsmedicare.com/jb/index.html
• Jurisdiction C: http://www.cgsmedicare.com/jc/index.html
• Jurisdiction D: http://med.noridianmedicare.com/web/jddme

Suppliers can also reference the Medicare IVIG Demonstration website to find educational material, such as frequently asked questions and beneficiary enrollment information and forms.

Q22. Will my current Medicare benefits be affected if I decide not to submit an application to enroll in the demonstration?
A22. No. Participation in the demonstration is voluntary and will not affect your current Medicare benefits or entitlement.

Q23. If I am approved for the IVIG Demonstration, how do I find a Medicare pharmacy supplier that provides and bills for the medication and the services to administer it under the demonstration?
A23. Once approved for the demonstration, take these steps:

1. If you already receive IVIG drugs in your home from a specialty pharmacy, tell your doctor and the specialty pharmacy provider 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.
2. If you don't already receive IVIG drugs in your home from a specialty pharmacy:
   
   A. 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.
   
   B. If you need to find a specialty pharmacy on your own, use the Medicare.gov website to find specialty pharmacies in your area:
   • From http://www.medicare.gov/, scroll down to the bottom of the page to the Take Action section.
   • Click on the Find medical equipment & suppliers link.
   • Enter your ZIP code.
   • In the Equipment box type infusion.
   • Click on the Search button.
   • A list of choices will appear. Check the box for Infusion Pumps not insulin and click Update on the bottom of the window.
   • A list of suppliers within 10 miles will appear.
   • To increase your search to a wider area, click the drop down arrow in the Filter by 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.

Q24. Once I submit an application, how long will it take before I find out my enrollment status and whether I've been enrolled in the demonstration?
A24. When an application is submitted, it is reviewed to make sure that it is complete. If critical information is missing (for example, a signature or your Medicare ID # is missing), you may be contacted and the application will be returned to you for the necessary information. If the application is complete, the information provided will be verified with Medicare's eligibility systems to confirm that you are eligible for the demonstration. This process takes approximately seven to eight days. You will then be sent a letter confirming your status. The IVIG demonstration support contractor has 10 business days to mail this letter after receipt of a completed application.

When your coverage begins is determined by when in the month your completed application was received. 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 15th 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.

Q25. Will l receive an enrollment card to use to show I am covered under the demonstration?
A25. No. You will only be notified of acceptance into the demonstration via a letter. Show this letter to the supplier that provides your medication to confirm that you are covered. Your supplier may also contact the Medicare IVIG Demonstration Call Center if they have questions about your coverage or billing.

Q26. I thought that Medicare covered IVIG treatment at 100% and therefore I don't have any out-of-pocket expenses. Why am I getting a bill or MSN that shows I'm partially responsible for these services?
A26. IVIG coverage is similar to many other Medicare Part B covered services; it is subject to coinsurance and deductible, which is the beneficiary's responsibility. Some beneficiaries may have a Medicare supplemental insurance that covers these costs. This coverage also is only payable in certain places of service and the beneficiary must have a covered diagnosis for the IVIG drug (and administration) to be paid by Medicare.

Q27. Why is the supplier questioning my PIDD diagnosis when I've been approved for the IVIG demonstration?
A27. Medicare only covers IVIG medication in the home for non-home-bound patients, when a patient has certain primary immune deficiency diseases (PIDD) as outlined for coverage in the Medicare IVIG coverage determination. The IVIG demonstration application form does not ask for the specific PIDD diagnosis, but only requires a treating physician signature, stating that the beneficiary has PIDD. Since only certain PIDD diagnoses are covered for IVIG, suppliers may request more specific documentation about the patient's diagnosis before providing services covered under the demonstration. If you have further questions about your PIDD diagnosis, contact your treating physician.