That’s right. GS1 and HIBCC are in a multi-year fight over the dominance of their standards within the U.S. healthcare supply chain. The U.S. healthcare supply chain is split into two chains: pharmaceuticals and medical devices. While the FDA regulates both supply chains and many companies participate in both, there are differences in the standards that have been used historically in each. The biggest differences are in the unique product identification and location identification.
HEALTHCARE PRODUCT CODE STANDARDS
FDA created the National Drug Code (NDC) system back in 1972 and mandated its use for all drugs. At the same time, FDA also created a compatible numbering system called the National Health Related Item Code (NHRIC) for devices but it was apparently voluntary and is apparently now obsolete. FDA is currently working on the definition of a new numbering system for devices—known as the Unique Device Identification (UDI) system. The development of the UDI system was one of the initiatives kicked off by the Food and Drug Administration Amendments Act of 2007. Until UDI is complete, identifiers used for medical device have not been governed by the FDA so companies have been left to make their own decisions about them.
The U.S. Department of Defense (DoD) didn’t like this situation because it caused confusion in their product ordering and receiving so in 1995 they created the Universal Product Number (UPN) system for medical devices. They defined a UPN in such a way that the product numbering systems of two competing industry standards organizations could be used. The Health Industry Business Communications Council (HIBCC) applied their Labeler Identification Code (LIC), and the Uniform Code Council (now GS1 U.S.) applied their GS1 Company Prefix (GCP) as the basis of their UPN’s. HIBCC appended their 4-alphanumeric-character LIC with a 1 to 18 alphanumeric character product code to form their UPN. GS1 appended their variable length numeric GCP with a variable length numeric product code to form their 14-digit UPN (also known as a Global Trade Item Number, GTIN-14). A company must pay a fee to HIBCC if they want to obtain a LIC and a fee to GS1 U.S. if they want to obtain a GCP.
Because the DoD doesn’t need to buy every possible type of medical device, not all devices currently passing through the U.S. supply chain have a DoD-compliant UPN.
HEALTHCARE LOCATION CODE STANDARDS
HIBCC and GS1 U.S. also compete in the healthcare location code standards arena. HIBCC has the Health Industry Number (HIN) standard and GS1 has the Global Location Number (GLN) standard. The HIN and GLN differ in multiple ways. First, the HIN is composed of nine alphanumeric characters assigned by HIBCC, while the GLN is 13-digit number composed of the same GCP found in the GTIN UPN plus a Location Reference that is selected by the owner of the GCP. It’s an important difference that HIBCC assigns the entire HIN because it means that there is a single point of control for these numbers. Because each end-user company can define their own GLN’s, GS1 U.S. has to have a GLN registry so that companies can find the GLN’s for their trading partners. It’s called the GS1 U.S. GLN Registry for Healthcare.
The funding of the HIN and GLN systems are another important difference because of what results. The assignment of HIN numbers is done by HIBCC for each manufacturer, wholesaler, pharmacy and provider location in the supply chain without those organizations requesting it. The cost of this “automatic” number assignment is covered by HIBCC. GS1 GLN’s are only defined when a GS1 GCP subscriber decides to create one. This means that companies who already own a GCP do not have to pay additional fees to create GLN’s for their locations. (GS1 also sells individual GLN’s for a lower fee for smaller companies who do not need the full capability of a GCP.) HIBCC does not charge for listing a company’s HIN’s in their HIN databases, but they do charge for access to those databases. GS1 charges a fee to list and access their GLN registry. For these reasons, the HIBCC HIN databases should contain the HIN’s for every location in the entire healthcare supply chain, but the GS1 U.S. GLN Registry for Healthcare will contain only those locations for companies who choose to pay for a GCP or an individual GLN, and who choose to pay to be listed in their registry. Currently, that’s not as many companies.
One of the problems with industry reliance solely on the GS1 GLN for location identification is that smaller companies, like independent pharmacies, are unlikely to bother acquiring a GCP or a GLN. Industry reliance solely on the HIBCC HIN doesn’t have this problem because smaller organizations don’t have to pay anything or initiate any action whatsoever for a HIN to be created for their locations. HIBCC does that on their behalf.
HIBCC was originally formed with the purpose of developing standards for use in the medical devices side of the healthcare supply chain. On the other hand, the HIBCC HIN was widely adopted on both sides of the supply chain. GS1 GTIN’s have be used in the pharmaceutical side for many years because early on, GS1 reserved the FDA Labeler Code number space used as the basis of the NDC within their GCP number space. Pharmaceutical manufacturers still had to register their Labeler Code and pay a fee to GS1 before they used their FDA Labeler Code as a GCP, but this reservation ensured that there would not be any clashes in the future.
In the title of this essay I called it a war. That’s not much of an exaggeration. In my observation, what is going on right now between HIBCC and GS1 is aimed at the total elimination of the other. GS1 is usually the aggressor and HIBCC is usually found in a defensive posture. There is lots of evidence of this on the internet. Here are a few pieces I have found.
- Check out the opinion of the “Editor” in his/her remarks at the top of this Loftware Blog post from last year. Yow, that’s blunt.
- Here is a copy of an article called “Standards Movement Shifts Toward GS1 Version”, from a March 2009 edition of the Hospital Materials Management Newsletter that is hosted on the HIBCC website.
- Here is a HIBCC newsletter from 2008 that contains multiple articles about the war from HIBCC’s perspective. In fact, most of the articles in the issue take up various aspects of the war.
- Here is a recent article about the HIBCC Vs. GS1 “debate” from the February 2010 edition of Repertoire Magazine called “Is One the Loneliest Number?”.
- Perhaps the salvo that GS1 has made that is the most harmful to HIBCC is their success in getting multiple large hospital group purchasing organizations (GPO’s) and other healthcare organizations to announce that they are adopting/embracing GS1 standards—presumably at the expense of HIBCC standards. GS1 is rightfully so proud of these and other related announcements that they have collected links to them all on a single page.
- The GPO’s have established two programs designed to push the supply chain to adopt GS1 GLN’s and GTIN’s on an aggressive schedule. These are Sunrise 2010 for GLN and Sunrise 2012 for GTIN. GS1 promotes these programs at every opportunity, but they carefully point out that these are not GS1 programs but those of “organizations and companies throughout the U.S. healthcare supply chain”, yet you can’t find anyone else who claims to own them. Obviously GS1 owns them, but for some reason they don’t want to admit it.
- I have covered several aspects of this debate in previous posts. This one about a flawed AHRMM sponsored survey that clearly favored GS1 and this one about the perceived “rush” to GS1 standards in the healthcare supply chain.
- GS1 has signed “memorandums of understanding” (MoU’s) with a number of other standards development organizations which, in effect, establishes a treaty between them that defines the type of standards that each organization can develop without encroaching on the other. GS1 has MoU’s with HL7 and ICCBBA. No such understanding exists between GS1 and HIBCC because there is already too much overlap in their standards.
- In 2008 HIBCC adopted their own RFID standard that follows ISO standards so that it is at least interoperable with GS1’s EPCglobal RFID standards. See also this.
Will this war ever end as long as both sides are still standing? Maybe. If HIBCC is to survive they will have to find a way to co-exist with GS1 standards. I have an idea that could remove part of the wedge that seems to force companies to think they have to align with one standards company or the other. I’ll share my idea in a future post. (See that future post at Masterpiece: GS1 Tag Data Standard 1.5.)