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Correct billing for NDC number

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Q.

I filed a claim that included ISOVUE 300 and I reported the National Drug Code (NDC) that was on the vial. The claim was denied saying that the NDC number was incorrect. Can you give me the correct number? 

A.

The official FDA NDC number is a 10-digit number. However, when the Centers for Medicare and Medicaid Services’ (CMS) claim form was revised several years ago, an 11-digit code was required. That mandates you to add an additional 0 (zero) within the official NDC number for billing purposes. 

For Bracco products, that extra 0 goes at the beginning. Here are the ISOVUE®-300 (Iopamidol Injection 61%) Injection billing NDC numbers: 

NDC No.              Drug Name HCPCS dosage                          DESCRIPTION
00270-1315-25    ISOVUE®-300 (Iopamidol Injection 61%)      Ten 30 mL vials
00270-1315-30    ISOVUE®-300 (Iopamidol Injection 61%)      Ten 50 mL bottles
00270-1315-35    ISOVUE®-300 (Iopamidol Injection 61%)      Ten 100 mL bottles
00270-1315-45    ISOVUE®-300 (Iopamidol Injection 61%)      Ten 200 mL bottles IBP
00270-1315-95    ISOVUE®-300 (Iopamidol Injection 61%)       Six 500 mL bottles IBP

INDICATIONS AND USAGE | IMPORTANT SAFETY INFORMATION

ISOVUE® (Iopamidol Injection)

Indications and Usage:

ISOVUE®-200, 250, 300, 370

ISOVUE® (Iopamidol Injection) is indicated for angiography throughout the cardiovascular system in adults, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, selective visceral arteriography and aortography, peripheral venography (phlebography), and in pediatric patients for angiocardiography, or for adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head and body imaging.

ISOVUE®-300 (Iopamidol Injection 61%) and ISOVUE®-370 (Iopamidol Injection 76%) Imaging Bulk Package*

ISOVUE® (Iopamidol Injection) Imaging Bulk Package (IBP) is indicated for angiography throughout the cardiovascular system in adults, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, selective visceral arteriography and aortography, peripheral venography (phlebography), and in pediatric patients for angiocardiography; or for intravenous contrast enhancement of computed tomographic (CECT) imaging of the head and body in adult and pediatric patients.

*The ISOVUE (Iopamidol Injection) Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.

Indications and Usage for ISOVUE®-250 (Iopamidol Injection 51%) Pharmacy Bulk Package**

ISOVUE® (Iopamidol Injection) Pharmacy Bulk Package (PBP) is indicated for adult and pediatric intravenous excretory urography.

**The ISOVUE (Iopamidol Injection) Pharmacy Bulk Package is Not for Direct Infusion.

IMPORTANT SAFETY INFORMATION:

ISOVUE (Iopamidol Injection) IS NOT FOR INTRATHECAL USE. Iopamidol Injection is available as ISOVUE-M 200 (Iopamidol Injection 41%), and ISOVUE-M 300 (Iopamidol Injection 61%) for intrathecal administration. 

Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. 

As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history. As with any other iodinated contrast media, caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit  www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for ISOVUE (Iopamidol Injection) here. 

Please see full Prescribing Information for ISOVUE Imaging Bulk Package products here. 

Please see full Prescribing Information for ISOVUE (Iopamidol Injection) Pharmacy Bulk Package here.

ISOVUE-M is currently manufactured for Bracco Diagnostics Inc. at three locations: BIPSO GmbH, Singen (Germany), Patheon Italia S.p.A., Ferentino (Italy) and S. M. Farmaceutici SRL, Tito (Italy).

ISOVUE-M is a registered trademark of Bracco Diagnostics Inc.