The pharmacy services sector of the health care industry has a business need to report the device identifier (DI) of the Unique Device Identifier (UDI) in the Health Care Claim Remittance/Advice (835).
The FDA final rule was released September 24, 2013 requiring a Unique Device Identification System for Medical Devices. As a result of this ruling NDCs issued for medical devices will be rescinded by the FDA and NHRICs will be phased out. Beginning in September 2016, Class II devices will have the UDI on packages and in September 2018, Class I devices will have the UDI on the packages.
In September 2016, the pharmacy services industry will begin using the UDI-DI portion in the NCPDP claim transaction for billing and payment purposes; and therefore, need the ability to report the UDI-DI component on the ASC X12 835 transaction. Today, pharmacy products and services codes are reported in Loop 2110, SVC01-2 with the appropriate qualifier in Loop 2110, SVC01-1. What qualifier should be used to report the UDI-DI?
In guide 005010X221A1, the SVC01-01 Procedure Code Qualifier element doesn't support reporting of the UDI-DI in the 835. Please submit a detailed change request to ASC X12N for inclusion of this information in a future guide at http://changerequest.x12.org/.
As a temporary work around, consider reporting the UDI-DI in SVC01-02 using SVC01-01 qualifier UI, “U.P.C Consumer Package Code (1-5-5)”. Request a Remittance Advice Remark Code (RARC) through http://www.wpc-edi.com/reference/codelists/healthcare/remittance-advice… with a description like “Alert: The reported UPC code(s) for this service in SVC01 and SVC06 (if present) is a Unique Device Identifier (UDI) – Device Identifier (DI) code.” Then, report that RARC in the 2110 loop LQ segment for service lines reporting the UDI-DI. NOTE: HIPAA regulatory aspects of this request and recommendation need to be addressed directly with the National Standard Group at CMS.