CMS reverses course, agrees to unique device identifiers (UDIs) despite unknown costs.
FDA admits that its current system for tracking medtech malfunctions, patient injuries, and deaths could be better--a lot better. Now, its top officials may be closer to doing something about it.
In a JAMA editorial published this week, FDA commissioner Robert Califf and Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health (CDRH), called for creating a national medtech evaluation system first proposed in 2012.
The current system, in which clinicians report adverse events that they believe are tied to medtech, probably leads to underreporting and does not generate the exposure data to enable patient risk calculations, they write. Meanwhile, medtech safety issues often go unidentified until multiple patients get hurt or die, such as during the superbug outbreaks linked to dirty Olympus duodenoscopes. FDA didn't warn hospitals about the problem until the LA Times reported that duodenoscope-related infections killed three patients at a UCLA hospital.
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More than 50,000 serious adverse events are reported annually, including over 3,000 deaths, according to a 2015 FDA report.
"Even though the FDA can require device makers to perform postmarket studies, patients have few incentives to enroll in a study once a device is marketed, and many FDA-mandated postmarket studies for devices have been delayed, scaled back, or never finished," the JAMA article says. "Generally, if the company makes a good-faith effort in performing postmarket studies, there are no penalties."
Califf and Shuren acknowledge that FDA needs to balance the risk of stifling innovation by raising premarket standards, with improved postmarket tracking. They propose using clinical data, advanced analytics, and "flexible regulatory approaches" to create "a more comprehensive and accurate framework" to assess the risks and benefits of devices.
"An ideal approach would match the degree of premarket evaluation with the degree of probable risk and benefit posed by the device, while emphasizing rigorous postmarket evaluation in conjunction with carefully planned premarket clinical studies," they write.
FDA already has the framework for this. The agency took the first steps toward establishing a National Evaluation System for Health Technology (NEST) in 2012.
"Essentially, NEST should be of, by, and for the medical device ecosystem and configured to provide maximal value to stakeholders, including the critical data needed by the FDA to make decisions that currently must be made with less comprehensive information," the editorial says.
But NEST would require unique device identifiers (UDIs), which CMS has fought as too complicated and costly to include on medical claims forms from hospitals, despite 2007 Congressional legislation requiring them.
Now, CMS has come around. A letter from acting HHS administrator Andrew Slavitt and Califf to the quasi-public agency that sets medical billing document standards says that collecting UDIs would lead to greater safety and innovation, and aid in provider and payer cost control.
"We recognize that collecting the DI is complex and requires providers changing their workflows and billing systems as well as requiring public and private payers, entities that bill for providers, clearinghouses and other entities to change their claims processing systems," the letter says. "CMS also needs to modify numerous legacy computer systems to collect DIs for implantable devices on Medicare claims, which would require additional funding and resources."
This isn't a done deal, however. The medical billing panel, known as the Accredited Standards Committee X12, would still have to agree to the change. X12 is scheduled to issue recommendations to the billing industry by December, according to a report by the Wall Street Journal.
Nancy Crotti is a contributor to Qmed.
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