Change Request Detail
No.
1181
Date
10/30/2012
Submitter
Type of Request
Pertaining to more than one, or not sure
Status
DSMO Process Completed
Business Reason
RFI # 1672 was opened with X12 regarding the ability to report NHRIC's in the 837P.  The response from X12 was that '....if there is a business need to report this information that it be submitted through the DSMO process....'

Description of RFI 1672 to X12:

NHRIC's - National Health Related Items Codes - Are assigned to Medical Devices by the FDA. They are different from NDC codes.

With HCPCS code J7321, some payers are looking for the NHRIC code (08363-7761-01 for this example) which they are mistaking for an NDC code. We are experiencing this same issue with other medical devices which are typically injections used for orthotic purposes.

How can this be reported in the 837P 5010? I did not find a segment for this code and it can not be sent in the 2410 loop LIN segment because these codes are not listed in code set 240 for NDC codes.
Suggestion
Our clients are reporting the NHRIC code in the 2400 LIN segment.

Would it be possible to add a qualifier and code set for NHRIC codes in the  2400 loop LIN segment of the 837P transaction and any other transaction that could possibly utilize this?

From the FDA:

National Health Related Items Codes (NHRICs) and New Drug Codes (NDCs):
New Drug Codes (NDCs) do not apply to medical devices.  Instead, National Health Related Items Codes (NHRICs) are used to uniquely identify medical devices. The NHRIC is comprised of two components - the labeler code and the sequential number. The former is obtained by manufacturer application to the FDA. When this labeler code is obtained, the manufacturer completes the product by assigning a sequential number for the medical device. When this is completed, the manufacturer assumes ultimate responsibility of maintaining the NHRIC number. Below is a link describing NHRICs, as well as the NHRIC database. You may use the latter to search for the NHRIC number.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm161456.htm 
DSMO Category
D
Recommendation
Disapprove.  The DSMO disapproves this request because the code set is not a HIPAA adopted code set.  The submitter is invited to resubmit a change request after the FDA has issued final regulations for unique device identification. The unique device identification could replace the use of the NHRIC. The submitter is then requested to include clear business justification and specific usage for the use of NHRICs in each transaction in the request in conjunction with identifying the code set(s) being used for NHRICs under HIPAA.
Appeal Recommendation