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IVIG Demonstration Supplier Frequently Asked Questions

Q1. What is the Medicare Intravenous Immune Globulin (IVIG) Demonstration?
A1. The Medicare Intravenous Immune Globulin (IVIG) Demonstration is being implemented to evaluate the benefits of providing payment for items and services needed for the in-home administration of intravenous immune globulin for the treatment of primary immune deficiency disease (PIDD). This is a three year demonstration, which will enroll no more than 4,000 Medicare beneficiaries nationwide. Under this demonstration, Medicare will provide a bundled payment under Part B for items and services that are necessary to administer IVIG in the home to enrolled beneficiaries who are not otherwise homebound and receiving home health care benefits. The demonstration only applies to situations where the beneficiary requires intravenous immune globulin for the treatment of PIDD, or is currently receiving subcutaneous immune globulin to treat PIDD and wishes to switch to intravenous immune globulin.

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 in the same manner as other Part B services.

Q2. How do beneficiaries enroll in the demonstration?
A2. 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:

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
900 42nd St S
Fargo, ND 58103

Or fax applications to: 701-277-2428

Applications for participation in the IVIG Demonstration will be accepted on a rolling basis until Medicare reaches or projects it will reach the statutory limit on funding and/or enrollment. Beneficiaries will be notified within 10 calendar days of receipt of a complete application of their status and the effective date of their coverage under the demonstration. Completed applications received by the 15th of the month, if eligible, will have coverage effective the 1st of the next month. Completed applications received after the 15th of the month, if eligible, will have coverage effective the 1st date of the month following the next month. For example, if an application is received on September 15th, coverage will be effective October 1st. If an application is received on the September 20th, coverage will be effective November 1st.

Q3. How long will the demonstration last?
A3. This is a 3 year demonstration and will continue through 9/30/2017, pending availability of funding.

Q4. Is this demonstration applicable to IVIG administered subcutaneously?
A4. No. The demonstration is only applicable when the beneficiary is receiving the immune globulin intravenously. This demonstration does not apply if the immune globulin is administered subcutaneously. Nothing in this demonstration will impact how the subcutaneous administration of immune globulin (SCIG) is covered and paid for under the original Medicare FFS program.

Q5. What is the HCPCS code for the administration of IVIG drugs?
A5. The code is Q2052 (Services, supplies and accessories used in the home under Medicare Intravenous immune globulin (IVIG) demonstration). Q2052 is for use with the IVIG demo only.

Q6. How is code Q2052 billed?
A6. The demonstration service code must be billed as a separate claim line on the same claim for the same place of service as the IVIG drug. In cases where the drug is mailed or delivered to the patient prior to administration, the date of service for the administration of the drug (the "Q2052" claim line) may be no more than 30 calendar days after the date of service on the drug claim line and within the same calendar year.

No more than one unit of demonstration services (Q2052) shall be billed per claim line.

If a provider is billing for multiple administrations of the IVIG on a single claim, then the provider shall bill the "Q2052" code for each date of service on a separate claim line and will be payable each time the IVIG is administered. While this is expected to be approximately monthly, it may more or less frequent depending upon a patient's medical need. Thus, there may be situations in which multiple units of the drug are shipped to the patient and billed on a single "J" code claim line followed by more than one "Q2052" administration claim lines, each with the date of service on which the IVIG was administered.

Q7. Which IVIG Drugs are covered under the demonstration?
A7. The following "J" codes represent Immune Globulin drugs that are administered intravenously and payable under Medicare Part B for services rendered in the home (or home-like setting) for beneficiaries with primary immune deficiency syndrome (PIDD).

  • Bivigam, J1556
  • Flebogamma, J1572
  • Gammagard liquid, J1569
  • Gammaplex, J1557
  • Gamunex, J1561
  • IVIG, NOS (lyophilized), J1566
  • IVIG, NOS (non lyophilized), J1599
  • Octagam, J1568
  • Privigen, J1459

This list is subject to updates if there are changes to drug coverage for IVIG for primary immune deficiency disease under Medicare Part B.

Q8. If a beneficiary is in a home health episode can these claims be billed to the DME MAC?
A8. No. If the beneficiary is receiving home health services the drugs and services are included in the home health billing, and are not eligible for the demonstration.

Q9. If a beneficiary is in hospice can the IVIG demonstration claims be billed to the DME MAC?
A9. Yes. If the IVIG and administration is not related to the hospice diagnosis, the GW modifier would be appended to the affected HCPCS to receive reimbursement.

Q10. If the beneficiary is not enrolled in the demonstration but is receiving IVIG in the home may I obtain an Advance Beneficiary Notice of Noncoverage (ABN) and bill the patient for the Q2052?
A10. No. An ABN cannot be obtained. The administration services and supplies (Q2052) can only be billed for beneficiaries enrolled in the demonstration.

Q11. Are claims for demonstration services subject to sequestration?
A11. Yes. Claims for demonstration services are subject to sequestration to the same extent as any other claims submitted by suppliers to the DME MACs for processing.

Q12. Where can I find more information?
A12. For more information, see the CMS Medicare IVIG Demonstration website, http://innovation.cms.gov/initiatives/IVIG/ This link will take you to an external website.

In addition, visit the Noridian IVIG Demonstration website, http://med.noridianmedicare.com/web/ivig

Q13. How does a supplier confirm if a beneficiary is eligible for the IVIG demonstration?
A13. The supplier should first ask the beneficiary. All beneficiaries who are approved for the IVIG Demonstration will receive an approval letter. Applications will continue to be accepted as long as space is still available. All applications will be reviewed and beneficiaries will be notified of their acceptance.

Q14. Who should a supplier contact for claim specific questions related to the IVIG demonstration?
A14. For IVIG demonstration claim specific questions, contact the DME MAC jurisdiction that processed the claim based on the beneficiary's address.

Q15. Will the demonstration impact coverage or payment for the IVIG drug?
A15. No. Nothing in the demonstration will change coverage policies or payment amounts for the IVIG drug. Coverage and payment for the immune globulin drug will be the same as it is in the absence of the demonstration.

Q16. Is Medicare covering pumps for the administration of the IVIG under the demonstration?
Q16. Under the demonstration, Medicare is not changing any of its current coverage policy regarding the use of pumps for the administration of IVIG. It is up the supplier to determine the services and supplies are appropriate and necessary to administer the IVIG in any given situation. This may or may not include the use of a pump. Medicare is not paying separately for the pump under this demonstration.

Q17. Does a pharmacy supplier need to enroll to provide the IVIG drugs and administration in this demonstration?
A17. No. The supplier does not need to enroll in the demonstration. However, the supplier must be currently eligible to bill the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) for IVIG, and meet all regulatory and statutory requirements to provide the administration.

Q18. Is the DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics and Supplies) Supplier required to be certified to bill the A/B MACs in order to provide the nursing component of the Q2052 - Services, Supplies and Accessories Used in the Home under the Medicare IVIG Demonstration?
A18. No. The DMEPOS supplier must currently be able to bill the DME MACs (enrolled and current with the National Supplier Clearinghouse) and meet all regulatory and statutory requirements. If a State requires licensure to furnish certain items or services, a DMEPOS supplier: Must be licensed to provide the item or service; and may contract with a licensed individual or other entity to provide the licensed services unless expressly prohibited by State law. A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care programs or from any other federal procurement or non-procurement programs.

Q19. Can the supplier/pharmacy contract or subcontract nursing services for the administration of the IVIG to bill the Q2052 - Services, Supplies and Accessories Used in the Home under the Medicare IVIG Demonstration?
A19. Yes. If a State requires licensure to furnish certain items or services, a DMEPOS supplier: Must be licensed to provide the item or service; and may contract with a licensed individual or other entity to provide the licensed services unless expressly prohibited by State law.

A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care programs or from any other federal procurement or non-procurement programs.

Q20. For the IVIG demonstration, does the supplier have to have a valid detailed written order which includes the Q2052 or an appropriate narrative (for example: services and supplies for home infusion of IVIG) prior to submitting the claim to Medicare?
A20. Yes. Detailed written orders are required for all transactions involving DMEPOS.

If a supplier does not have a faxed, photocopied, electronic or pen and ink signed detailed written order in their records before they submit a claim to Medicare (i.e., if there is no order or only a verbal order), the claim will be denied.

All current Medicare regulations apply to the IVIG demonstration.

Q21. How much will Medicare pay for the administration of IVIG under the demonstration?
A21. The 2015 allowable was $319.23; the 2016 allowable is $336.05 for all services and supplies related to the administration of the IVIG (Q2052). As with other Medicare Part B services, this is subject to coinsurance and deductible as well as sequestration. Although Medicare will pay separately for the immune globulin medication, no additional payment will be made for any other services and supplies used during the administration of the IVIG.

Q22. How do suppliers handle claims for beneficiaries who are enrolled in the IVIG Demonstration, and the administration code (Q2052) was not submitted on the same claim as the drug?
A22. The supplier would request a written reopening with the reason noted on their request. For example: "We learned that this beneficiary is enrolled in the IVIG Demonstration. Because the demo administration code (Q2052) must be billed on the same claims as the drug code, please reopen CCN XXX and add this service line for Q2052."

When there are multiple claims where the Q2052 has not been added to the same claim as the drug, the supplier can add a spreadsheet of the affected claims to the written reopening request.

Q23. What is covered under the Medicare IVIG Demonstration payment?
A23. Under the demonstration, Medicare is making a bundled payment for all services and supplies related to the administration of the IVIG medication to a beneficiary in the home. In 2016, the allowable payments for this bundled service (Q2052) is $336.05, and, as with other Medicare Part B services, is subject to coinsurance and deductible, as well as sequestration.

As a bundled payment, no additional payment will be made for any other services or supplies used before, during or after the administration of the IVIG. Such supplies and services may include travel time, needles, tubing, saline, pumps, peripheral IV supplies, etc. and the beneficiary may not be charged for these services or supplies. Medicare will only pay separately for the IVIG medication in accordance with the coverage and payment rules under the traditional Medicare fee-for-service program.

Last Updated Oct 11, 2016