UDI - pushing on a string

A post from August 2014 gave the FDA plaudits for passing the Unique Device Identifier (UDI) identification system (i.e. UDI labeling requirements plus the Global Unique Device Identification Database, or GUDID), but noted that its use by providers, etc. was not required and that many other things would have to happen to fully realize the program's benefits. So, what advances, if any, have we had since then? Well there was a flurry of UDI-related activity this month, including:

Earlier this month the FDA issued a final rule amending its post-market electronic Medical Device Reporting (eMDR) to align it with the use of UDI, for example including UDI in its Form 3500 which is used for adverse event reporting...

Also this month, the Wall Street Journal reported on an inter-agency disagreement, with the Center for Medicare and Medicaid Services (CMS) pushing back on FDA efforts to have UDIs included on medical claims: "... The Obama administration’s Medicare agency, in a behind-the-scenes bureaucratic conflict, has dug in its heels and opposes the FDA’s plan to use claims data with ID numbers to monitor safety, according to people familiar with the events. The Centers for Medicare & Medicaid Services, or CMS, says putting the identifying number—the UDI—on medical claims forms it receives from hospitals poses big technical hurdles and costs too much..." A number of parties immediately pushed back, including Aetna's chief medical officer.

Finally, this week the CMS issued its proposed Stage 3 'meaningful use criteria' changes while the Office of the National Coordinator for Health IT (ONC) issued its proposed '2015 Edition Health IT Certification Criteria.' The ONC proposed 2015 criteria include § 170.315 (a)(20) Implantable Device List: "... We propose to adopt a new 2015 Edition certification criterion focused on the ability of a Health IT Module to record, change, and access a list of unique device identifiers (UDIs) corresponding to a patient’s implantable devices (“implantable device list”), parse certain data from a UDI, retrieve the “Device Description” attribute associated with a UDI in the Global Unique Device Identification Database(GUDID), and make accessible to a user both the parsed and retrieved data.The proposed criterion represents a first step towards enabling health IT to facilitate the widespread availability and use of unique device identifiers to prevent device-related adverse events, enhance clinical decision-making related to devices, improve the ability of clinicians to respond to device recalls and device-related safety information, and achieve other important benefits..." However the CMS' proposed eight new Stage 3 meaningful use objectives/measures do not include the use of UDI.

The bottom line? One wonders how far the utilization of UDI by providers will go, and how long the uptake will take to happen absent the pressure provided by government requirements. While the benefits are clear (e.g. as articulated by the FDA, or by a provider - Mercy/ROi) that often is not sufficient to induce change in a timely fashion given that it will require time and effort...

Those who feel strongly about UDI adoption can send in written comments or comment via regulations.gov between March 30th and May 29th, 2015. I assume that these entities will continue to push for UDI use to be added to the CMS' objectives/measures.

What about you?

March 30th update: If you want to comment on the proposed rule: navigate to regulations.gov and search on 'RIN: 0938-AS26' (without quotes) to get to the "Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 (CMS-3310-P)" docket folder from where you should be able to upload your comment.

May 4th update: The FDA just made the Global Unique Device Identification Database (GUDID) publically available...

July 15th update: Read Some progress on UDI for a correction and additional developments.