Correct Coding - U 500 Insulin for Use in External Insulin Infusion Pumps

Joint DME MAC Publication

Recently the PDAC was notified by Lilly, the manufacturer of Humulin® R U-500 insulin, that its use in external insulin infusion pumps is considered "off-label." The impacted NDC code is 00002-8501-01. As a result, the CMS NDC J-code crosswalk was changed from J1817 (INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS) to J1815 (INJECTION, INSULIN, PER 5 UNITS).

Off-label use of medications is allowed by Medicare (see Benefit Policy Manual, Internet-only manual 100-02, Ch. 15, Section 50.4.2). When U-500 insulin is used in DME (i.e., an external insulin infusion pump), the correct code to bill is code J1817, not J1815. The NDC crosswalk will be updated to include this "off-label" use of the drug.

For questions about correct coding, contact the Pricing, Data Analysis and Coding (PDAC) contractor Contact Center at (877) 735-1326 during the hours of 9:30 a.m. to 5:00 p.m. ET, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact Form.

Revision History

Date Revision
12/21/2018 Published to PDAC website


Last Updated: 12/21/2018