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Provider and Supplier - 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 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.

Provider and Supplier

Treating Physicians

Treating physicians have the key role in determining whether IVIG can safely be administered in the home for an individual Medicare beneficiary. If so and the beneficiary meets other demonstration criteria, the physician will then be asked to sign the beneficiary application form attesting that you are treating the patient, that the patient has primary immune deficiency disease and is a candidate for home IVIG.

Suppliers

Once a beneficiary has been approved for the IVIG demonstration, the supplier that provides the drug may also bill for the in-home administration services, either that the supplier provided directly or through an entity that the suppliers contracts with for the administration services.  For more information on the supplier role in this demonstration, see below and also reference CMS Medicare Learning Network (MLN) Matters Special Edition (SE)1424 This link will take you to an external website.

Ways to Avoid Common Billing Errors Made on Demonstration Claims

Proper Billing for Dates of Service

When billing any of the IVIG drugs covered under the demonstration for a beneficiary with PIDD, a date span must not be used. The drug must be submitted with the same from and to date on the claim.

Q2052, the administration code, must be billed as a separate claim line on the same claim for the same place of service as the IVIG drug. When Q2052 is billed alone, the claim will be denied.

In cases where the drug is mailed or delivered to the patient prior to administration, suppliers should not bill the drug until the administration (the "Q2052" claim line) has been performed. Both services should be billed on the same claim and 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 must be within the same calendar year.

No more than one unit of Q2052 shall be billed per claim line.

Q2052 shall only be billed for beneficiaries enrolled in the IVIG demonstration.

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. Multiple administrations on a claim are payable but they should be for different dates of service. While the usual administration of IVIG drugs for PIDD is 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 line, each with the date of service on which the IVIG was administered.

End of the Year Billing

Services under the IVIG Demonstration that claims for the Q2052 and IVIG drugs must be billed within the same calendar year.

Example: The administration (Q2052) dates are 12/15/15 and 01/05/16 which are two different calendar years. There must be separate shipments for the IVIG drugs that will be administered for each calendar year.

The shipment for the drugs that will be administered on 01/05/2016 must also have a service date in 2016.

Drugs Covered Under IVIG Demonstration

The following drugs are covered under the demonstration for a beneficiary with Primary Immune Deficiency Disease (PIDD):

  • Bivigam, J1556
  • Flebogamma, J1572
  • Gammagard liquid, J1569
  • Gammaplex, J1557
  • Gamunex, Gamunex-C/Gammaked, J1561
  • IVIG, NOS (lyophilized), J1566
  • IVIG, NOS (non lyophilized), J1599
  • Octagam, J1568
  • Privigen, J1459
  • Rhophylac, J2791

Allowables

  • Q2052
    • 2014 $300.00
    • 2015 $319.23
    • 2016 $336.05
    • 2017 $354.60
    • 2018 $358.50
    • 2019 $366.25
    • 2020 $374.20

Education

Educational tutorials and other multimedia education opportunities are available. View the Educational Opportunities webpage for details. 

Last Updated Tue, 11 Feb 2020 10:11:55 +0000