Department of Health and Human Services, Centers for Medicare and Medicaid Services, Announces New J-Code for Vivaglobin ® Immune Globulin Subcutaneous J-1562.

On October 26, 2006, ZLB Behring, received notification from the Centers for Medicare and Medicaid Services (CMS) granting our request to establish a new Healthcare Common Procedure Coding System (HCPCS) code for Immune Globulin Subcutaneous (Human) trade name: Vivaglobin®; J1562 "INJECTION IMMUNE GLOBULIN, SUBCUTANEOUS, 100 MG." The new code is effective January 1, 2007. It is for use by all payers, including Medicare, Medicaid and Private Insurers.

Billing for Vivaglobin:

Since Vivaglobin® is a subcutaneous immune globulin product and is not administered intravenously, it is not appropriate to bill for the product using J1566 (injection, immune globulin, intravenous, lyophilized (e.g. powder), 500 mg) or J1567 (injection, immune globulin, intravenous, non-lyophilized (e.g. liquid), 500 mg). J1562 is the appropriate code when billing Subcutaneous Immune Globulin

Vivaglobin® is available in 3 convenient single use vials:

3 ml vial = 480 mg Vivaglobin®
10 ml vial = 1600 mg Vivaglobin®
20 ml vial = 3200 mg Vivaglobin®

The new code that CMS established for Vivaglobin® uses 100 mg as the unit of measure for the code. As a result, if billing for 1600 mg, the claim should include 16 service units for J1562. For uneven multiples of 100 mg, health care providers billing Medicare may bill consistently with the following provision at section 10 of Chapter 17 of the Medicare Claims Processing Manual (MCPM):

"Drugs are billed in multiples of the dosage specified in the HCPCS/NDC. If the dosage given is not a multiple of the Health Insurance Common Procedure Coding System (HCPCS) code, the provider rounds to the next highest units in the HCPCS description for the code."

Under this policy, 5 service units would be billed for 480 mg of Vivaglobin®. In addition, health care providers billing Medicare may bill consistently with CMS' policy on discarded drugs, which appears in section 40 of Chapter 17 of the MCPM:

"The CMS encourages physicians to schedule patients in such a way that they can use drugs most efficiently. However, if a physician must discard the remainder of a vial or other package after administering it to a Medicare patient, the program covers the amount of drug discarded along with the amount administered."

Under this policy, if a patient were to receive a 1500 mg dose of Vivaglobin® from a 1600 mg vial and the remaining 100 mg must be discarded, CMS policy would permit the billing of 16 service units of Vivaglobin®.

Health care providers should consult with other payers regarding their policies for billing for uneven multiples of Vivaglobin® and billing for discarded drug.

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Reimbursement Alert Online December 2006

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