A rule to establish a tracking system for medical devices – similar to a bar code – has been stuck at the White House Office of Management and Budget (OMB) since last July; everyone has been scratching their heads over the holdup. According to Brett Norman at Politico, “It’s a pick-your-sad-joke kind of situation!”
In 2004, the FDA initiates a barcode rule for all medical devices. In 2006, the FDA begins to hold government and industry meetings to plan for unique device identifiers (UDI) implementation. Congress authorizes the FDA to begin UDI regulations in 2007 with the FDA Amendments Act. Between 2007 and 2011 the FDA develops the proposed regulations and releases them in 2011. At this point, OMB places the regulations under review. Intense pressure is exerted on OMB as it is lobbied heavily to retract the review by Congressional, industry and interest group leaders. As of 2012, a pending FDA User Fee Bill includes language forcing FDA to publish a timeline for UDI implementation.
The FDA supports a robust UDI system, and has been working to phase in the program since it was enacted in 2007. Even though OMB has placed UDI under review, FDA has continued to hold multiple conferences and seminars with industry leaders. Clearly, the FDA is acting as if they assume it will be let through.
For this article, both the Internal Revenue Service (IRS) and the Centers for Medicare and Medicaid Services (CMS) chose not to officially comment on the delay, but all sources from media report seem to indicate that they’re on board as well. FDA cites safety concerns, regulatory simplicity, and simplified recall procedures as the benefits of UDI.
OMB’s actions on UDI have been one of those great Washington policy conundrums. OMB did not respond to multiple inquires for this article, which probably wasn’t surprising because reportedly they are not getting back to anyone on this topic. In the words of Brett Norman at Politico: “It’s a bit of a black box.” This is not to say there have not been phone calls, letters, and public shaming from Congressional and industry leaders. It is not uncommon for OMB to place extended review periods on large-scale regulations. However, the real mystery arises because no one has been able to pinpoint any individual problems or series of issues that OMB might have with UDI.
Up on the Hill
Basically, Congress is befuddled over why this regulation hasn’t been put into effect yet. This is not a partisan issue and it’s received essentially unanimous support when voted on. There are no discernible party lines or lobbies against UDI implementation. The pursuit of UDI implementation has been championed by Senators Kohl, Blumenthal, and Grassley. These senators are collaborating on a joint letter calling on OMB to lift their review and get things moving. They wrote “Due to our strong desire for a robust post-market environment, we are very concerned with the delayed implementation of the UDI.”
Both the Republican and Democratic Policy Committees spoke in support of UDI, and in a rare moment of reticence declined comment on why OMB is holding up implementation.
The upcoming FDA User Fee bill includes language pushing OMB to drop their review. The House version states that it must decide one way or another within four months of passage. The Senate bill states that OMB must act by the end of this year. The law appears to be on course for passage in July, but anything can happen. Staffers from Energy and Commerce observed that there’s no kind of enforcement trigger in the bill. It, however does send the message from Congress that enough is enough.
What are industry and interest groups saying?
The industry and medical device related interest groups all seem to be on board with UDI. Premier Inc. stated that “UDI is the missing link to better ensure patient safety protection.” Representatives of AdvaMed stated “We are committed to working with FDA and other stakeholders in developing a UDI system.”
However, AdvaMed has a few conditions including, UDI should be phased in over a series of years based off of risk class, and consumers of devices need to be vigilant in checking the status of their devices with FDA.
Dr. Gregory Daniel with the health policy group at the Brookings Institute recently indicated that UDI was a common sense program supported by almost everyone in the industry, but would be useless without appropriate implementation and utilization. He went on to observe that the potential benefits of UDI are greater access to electronic medical data, payer and provider safety assurances, and the tracking of expensive goods; all of which cannot be accomplished without the active involvement of patients. On costs, Dr. Daniel said the jury was still out, but the promise of UDI is that costs could go down due to the streamlining of a highly complex and inefficient system of medical device accountability. Despite not being able to offer an estimate for the OMB hold, Dr.
Daniel remains confident that UDI will move forward as expected soon. He said, “UDI is going to happen, has to happen, no reason it won’t happen.”
The benefits of UDI appear clear. Not the least of which is eliminating a disparate web of medical device tracking. Most believe that UDI will also cut down on administrative cost, to the benefit of all players. UDI offers the best alternative to this and will likely spur international cooperation and the gathering/compiling of electronic data. Congress is pushing FDA and OMB through legislation. Most observers expect UDI to move forward due to the bi-partisan nature of the issues accompanied by industry pressure. Despite their small policy/nomenclature differences, all factions have formed an essentially united front in support of implementation. When the User Fee bill passes, pressure should mount for OMB to lift their review.
Many believe there are massive benefits accompanying UDI. Electronic tracking of the use of devices could allow for better research and comparative studies by medical groups toward the effectiveness of new technologies. Epidemiological research could be greatly enhanced by a centralized series of data drawn from the entire health care market. Imagine the enhancements to patient safety UDI could represent. Imagine the potential of CMS analysts gaining a better appreciation for the exact medical effectiveness of a series of devices, allowing them to implement policies offering the greatest quality-for-cost.
William Feather once said “Conditions are never just right. People who delay action until all factors are favorable do nothing.” I am with those who say, let’s get a fire built up under OMB and see if we can’t get those UDI regulations to boil on out.
Note: The author wishes to specifically thank Ryan Ashley, Undergraduate, Columbian College of Arts and Sciences, a Political Science Major with a Focus in Public Policy, at the George Washington University, for his research contributions to this article.