The Centers for Medicare & Medicaid Services is reportedly balking at implementing the FDA’s unique device identifier program because of the cost and difficulty of integrating UDIs into electronic health records.
The U.S. Congress enacted the UDI law in 2007, intending to have the FDA use billing claims data with the UDI number to track medical device safety. Medtech companies began incorporating UDIs into their labelling last year.
But now CMS is opposing the UDI plan, saying the project is too large and expensive to implement, the Wall Street Journal reported yesterday.
Medicare administrator Marilyn Tavenner stepped down last month, but not before detailing the federal health insurer’s opposition to the UDI program, writing in a letter to a pair of senators that "including UDIs on claims would entail significant technological challenges, costs and risks" for Medicare, the newspaper reported.
“Mechanisms other than claims reporting for collecting UDIs would avoid the significant challenges and risks" of putting a number on Medicare bills, Tavenner wrote.
That stands in contrast to Tavenner’s former boss, U.S Health & Human Services secretary Sylvia Burwell, who wrote during her confirmation process last year that a similar program for drugs at the FDA "will ultimately benefit" by "incorporating UDIs into its claims data sources," according to the Journal.
HHS told the paper that it and the FDA and Medicare are "working closely … on the shared goal of incorporating UDIs into electronic health records."
The FDA and stakeholders in the UDI fight are urging Medicare to change its stance. Cardiologist Dr. Joseph Drozda Jr., a member of a pair of UDI-related committees, told the newspaper that Medicare and insurers could reap huge financial benefits from UDIs by pinpointing unsafe devices and halting further implants. Still, Medicare staffers on 1 of the committees wrote in emails that the agency "does not support any scenario wherein the UDI is integrated into a claim transaction, stored in claims history, or utilized anywhere in the claims adjudication and payment process."
Aetna’s (NYSE:AET) medical director, Dr. Phillip Lerner, said it’s "critically important" for Medicare to proceed, in part because private insurers generally follow Medicare’s lead in formatting their bills.
A completed UDI system "will improve quality and lower costs," Lerner told the Journal. "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."
In a brief written statement to the newspaper, Medicare said it’s working "to better understand and document the value, benefits and cost" of the UDI system.