Change Request Detail
No.
1093
Date
12/29/2009
Submitter
Type of Request
Pertaining to more than one, or not sure
Status
DSMO Process Completed
Business Reason
Modifications to the HIPAA implementation guides for electronic health care transactions are needed to allow for the identification of the Universal Product Number (UPN) for medical and surgical supplies.

Recent state and federal initiatives1 related to unique product identification requirements for medical and surgical supplies indicate a growing need to utilize unique identifiers on electronic health care transactions for patient safety and cost-containment purposes. 

Under the authority of the U.S. Department of Health and Human Services (HHS), the California Department of Health Care Services (DHCS) is conducting an evaluation of the UPN as an alternative HIPAA medical code set standard for medical supplies, pursuant to 45 Code of Federal Regulations (CFR) section 162.940 of the HIPAA Transactions and Code Sets (TCS) final rule.  This pilot project allows participating health care providers to submit the UPN on electronic health care claim transactions as part of a two-year study which ends June 30, 2011.  At the end of the evaluation period, DHCS is required to submit an outcome report which documents the results of the test, including a cost-benefit analysis, to a location specified by the Secretary by notice in the Federal Register.  According to the HIPAA Exception regulatory language, if the organization requesting the HIPAA exception recommends a modification to the standard, the HHS Secretary may grant an extension period for the exception until such time that a decision is made to modify the HIPAA standards.  Early evaluation of the UPN test results indicates that the outcome report will recommend a modification to section 162.1002 of the TCS medical code sets final rule to allow for the UPN as an alternative coding standard for medical supplies.

This DMSO change request is being submitted to ensure that the impacted HIPAA transaction implementation guides allow for UPN identification should the HHS Secretary elect to amend the HIPAA medical code set rule to allow for the UPN as an alternative coding standard for medical supplies. The new versions of the HIPAA ASC X12 (5010) and the National Council for Prescription Drug Programs (NCPDP) (D.0) transaction standards effective January 1, 2012 do not contain the necessary information needed to support the UPN coding standards being evaluated as part of the California UPN Demonstration Project.

The Universal Product Number (UPN) is a generic term used in reference to the various types of unique product identification systems for medical and surgical supplies supported by the American National Standards Institute (ANSI), such as the Health Industry Business Communications Council (HIBCC) and the GS1
Global Trade Item Number (GTIN).
Suggestion
Both the X12 and NCPDP transaction standards include product qualifiers that support UPN identification on health care transactions.  Utilization of these product qualifiers in the segments that currently allow for identification of the National Drug Code (NDC) will result in minimal modifications to future versions of the HIPAA implementation guides (IGs).  The X12 837 TG4 subcommittee is currently evaluating the X12 837 Professional and Institutional claim transactions for UPN identification in the 2410 Product Identification loop. 

The California UPN pilot is using the following X12 product qualifiers for UPN identification:
EN GTIN EAN/UCC - 13 Digit Data Structure
EO GTIN EAN/UCC - 8 Digit Data Structure
UK GTIN - 14 digit Data Structure
UP GTIN UCC - 12 Digit Data Structure
HI    HIBC (Health Care Industry Bar Code) Supplier Labeling Standard Primary Data Message (alpha-numeric)
ON Customer Order Number (this is intended for interim use only until specific standards are named by HHS used only for products not specified with a GTIN or HIBCC)

It is recommended that these qualifiers, and any other product qualifiers that are necessary to support the Unique Device Identification (UDI) regulation currently in development by the US Food and Drug Administration (FDA)1, be added to the impacted  HIPAA transaction standards.

The California UPN Pilot also allows pharmacy NCPDP claim and authorization transactions for certain medical supplies billed with the National Health Related Item Codes (NHRIC) and/or the Universal Product Codes (UPC) maintained on the First DataBank drug file.

Below is a list of X12 and NCPDP health care transactions that require modification to allow for UPN identification. It is recommended that the additional product qualifiers for UPN identification are added to the appropriate location in each HIPAA transaction standard:
    Health care claims or equivalent encounter information transactions
    Referral certification and authorization transactions
    Health care claim status transactions
    Health care payment/remittance advice transactions
    Coordination of benefits transaction
    Medicaid Pharmacy Subrogation

The National Uniform Billing Committee (NUBC) and the National Uniform Claim Committee (NUCC) should be consulted in this DSMO request to ensure that paper claim transactions are consistent with the proposed electronic modifications to support this business need.

  Federal initiatives:
    The US Food and Drug Administration (FDA) Amendments Act of 2007 includes language related to the establishment of a Unique Device Identification System, which will require the label of a device to bear a unique identifier. The FDA is in the process of developing regulations scheduled for release in 2010 to implement these requirements.
    In 2007, the US Department of Defense initiated a pilot to test the GS1 Global Data Synchronization Network (GSDN) and the Global Trade Identification Number (GTIN) for patient safety and cost-containment purposes related to medical supply purchase and distribution.
DSMO Category
D
Recommendation
Disapprove. The DSMO determined that the change request to add the capability for unique device identification to the transactions needs to be done at the same time as the request for a new HIPAA code set is submitted.

The submitter is invited to resubmit a change request to the DSMO and is requested to include clear business justification and specific usage for the use of UDI in each transaction in the request in conjunction with identifying the code set(s) being used for UDI under HIPAA.

In addition, as the FDA has not yet issued its regulations for unique device identification (UDI) and has indicated that UPN is outdated terminology, and has requested to discuss with SDOs any changes necessary to support their UDI initiative, we see this request as premature.

For X12 version 005010, maintenance incorporated the UPN qualifiers that CA Medicaid is currently using in the 837 Professional for their ongoing pilot.
Appeal Recommendation