Depending on your perspective, the professional football season may just have ended or it may be months away from starting anew, but two federal agencies supposedly with the patient’s interest in mind, have been doing a lot of senseless bobbing and weaving of late.
Eight years ago Congress passed the “unique device identifier” rule that required a specific identification number be affixed to implantable devices so they could be tracked in case of a recall due to a malfunction, for example.
The supply chain department keenly recognized this as a unique inventory management opportunity and charged to the lead in promoting it. Along the way, however, the UDI received the supply chain “franchise” tag, much like when a team bestows the title to a player it wants to protect from the temptation of more lucrative outside offers.
Unfortunately, because of that link to supply chain, the information technology world may not have taken UDI seriously enough. Why? Because UDI is as much about and for supply chain as electronic health records are about and for patients.
In an “ends justify the means” way, UDI is about safety.
The Food and Drug Administration supported the underlying logic by seeking to use UDI-embedded billing-claims form data to track medical device safety from the patient’s perspective. Last year the federal agency also agreed to work the UDI issue into EHR matters and issues of Meaningful Use. UDI proponents and safety advocates spied both these moves as the right thing.
Yet in a retread of the CIA-FBI sibling interagency sniping from a few years back, the Centers for Medicare & Medicaid Services decided to stir the pot. On her way out the door in late February, outgoing Medicare administrator Marilyn Tavenner lobbed the proverbial Molotov cocktail into the debate. She wrote in a letter to two senators that CMS objected to the use of UDIs on claims because they “would entail significant technological challenges, costs and risks” for the program.
Never mind that the Health and Human Services Secretary, to which both FDA and CMS report, expressed her support for incorporating UDIs into claims data sources – particularly for drug product safety.
This recalled the 1974 television show, “The Year Without a Santa Claus” with HHS playing the role of Mother Nature, and FDA and CMS serving as the squabbling Snow and Heat Miser brothers, respectively. In it, each wanted something from the other that he wouldn’t sacrifice.
Actually, what we got here is … [a] failure to pontificate.
Imagine if this FDA-CMS squabble resembled an enterprise-resource planning system implementation at a healthcare system. After the ERP vendor installs the finance module as the first of several modules, progress hits a snag when the human resources director balks that the HR module would cost the department too much after all. Ouch?
UDI represents a cog in a much larger wheel of interoperability, integration and efficient electronic workflow. These contribute deeply to patient safety, which also influences billing and reimbursement. In short, all of these systems working together seamlessly and transparently make the overall system work.
We know that the federal agencies, providers, payers and suppliers are scrambling at the line of scrimmage to deal with a host of competing priorities, including reimbursement reformulations, Meaningful Use and ICD-10 conversions. UDI represents just another ball to juggle.
However, this isn’t rocket science and shouldn’t strain credulity. Nor should it be a political bladder control display between two federal agencies trying to reform the healthcare system.
Someone needs to call an audible and reinforce how this all connects the dots. The clock is running down with the game on the line – a game we no longer can afford to lose.
