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 As a result of this ruling NDCs issued for medical devices will be rescinded by the FDA and NHRICs will be phased out.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 can begin using the UDI-DI portion in the claim transactions for billing and payment purposes; and therefore, need the ability to report the UDI-DI component on the ASC X12 837 Professional and Institutional transactions. Refer to Section 1.11 in the 5010 guides on current billing guidance. What qualifier and guidance should be used to report the UDI-DI?
here is no way to report the UDI-DI within the structure of the 005010X222A1 or 005010X223A2 guides in place of the NDC code. The 2410 loop, where NDC codes are reported, does not support the UDI as a code list or within the wording of the situational rule for the loop/LIN segment.
For the 005010X221A1 and 005010X223A2 guides, willing submitters can report the UDI-DI on pharmacy supplies where the NDC that would have been reported in the 2410 loop has been replaced by the UDI-DI using the 2400 loop SV1 (837P) or SV2 (837I) segment. Each segment has a Composite Medical Procedure Identifier element (SV101 or SV202). Component element 07 for the composite is the Description, which is situational. The situational rule includes "Required when, in the judgment of the submitter, the Procedure Code does not definitively describe the service/product/supply and Loop ID-2410 is not used....If not required by this implementation guide, do not send." Therefore, this element (SV101-07 or SV202-07) can be used by the submitter to send the UDI-DI for medical devices that previously were reported using NDC codes in loop 2410, however, this usage can't be required by the receiver. Since this element is a text field (minimum length 1, maximum length 80), a format of "UDI-DI XXXXXXXX" is suggested.