FDA, CMS At Odds Over Unique Device Identification (UDI) Implementation

By Jof Enriquez,
Follow me on Twitter @jofenriq

A conflict between the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) has hindered the implementation of an initiative to include medical device unique device identifiers (UDIs) in insurance claims.

Citing people familiar with the matter, the Wall Street Journal reports that CMS “has dug in its heels and opposes the FDA’s plan to use claims data with ID numbers to monitor safety.”

In a letter last month addressed to two senators, former CMS administrator Marilyn Tavenner reportedly reasoned that, “including UDIs on claims would entail significant technological challenges, costs and risks,” and opined that mechanisms other than claims reporting for collecting UDIs would avoid those challenges and risks.

Tavenner stepped down from her post in February, but documents show that other Medicare officials currently maintain the same stance against UDIs, according to the WSJ. However, Health and Human Services (HHS) Secretary Sylvia Mathews Burwell, who oversees both Medicare and the FDA, supports the inclusion of UDIs in claims data.

Despite its opposition, Medicare issued a statement recently that said that it is currently working “to better understand and document the value, benefits and cost” of the medical device tracking system, according to the WSJ.

The UDI program is designed as a safety mechanism against defective medical devices. Since 2013, in a phased approach, the FDA has begun to require manufacturers to put into each device a label containing a key called the device identifier (DI) that allows the user to retrieve a comprehensive data package about that device, according to the article Understanding The UDI Rule – A Guide For Medical Device Manufacturers on Med Device Online. The data is uploaded into an FDA database for future reference, for example, when a device fails.

Tavenner had proposed incorporating UDIs into electronic medical records or device registries to monitor adverse events or device failures, according to the WSJ. However, some experts say that such a mechanism would only work if patients get treated in the same facilities, which is not realistic. For instance, a patient could receive an implant in one state but get treated for an acute event in another state. Tapping large insurance databases would yield a pattern of device failures more quickly than relying on different electronic health records.

Quick detection of device failures could mitigate the impact of cases such as Medtronic’s Sprint Fidelis cardiac lead recall in 2007. By the time the FDA realized the leads were failing at an alarming rate, approximately 268,000 leads had been implanted. The WSJ says that the device would cost Medicare between $287 million and $1.19 billion over five years.

The UDI program aims to provide the FDA with timely and accurate information to protect public health, according to experts. The agency’s medical device chief scientist, William H. Maisel, told the WSJ in 2012 that, “the unique identifier is the real game-changer” when included in insurance claims.

Industry stakeholders are urging Medicare to support the inclusion of UDIs in insurance claims.

“If we don’t have information on the devices that are implanted, it makes it hard to know their quality and cost,” Dr. David Lansky, president and CEO of the Pacific Business Group on Health, told the WSJ. “We want to know which ones do the best job.”

Philip Lerner, national medical director of insurer Aetna Inc., said that CMS should allow UDIs in claims in order to lower costs and improve quality. “If we had those data, the model and the brand, we would have the ability to do clinical outcome studies comparing a device to another device,” he told the WSJ.