Dr. Richard Kahn, a professor of medicine at the University of North Carolina and former chief scientific and medical officer of the American Diabetes Association, wrote in a commentary in Roll Call that it is openly acknowledged, with much supportive data, some blood glucose monitors do not meet U.S. Food and Drug Administration accuracy standards.
Almost all of the problems are with low-cost products manufactured overseas, Kahn said.
This year, the Centers for Medicare & Medicaid Services implemented a competitive bidding program for durable medical products such as blood glucose meters with the goal of reducing healthcare costs without sacrificing quality. A pilot program in nine markets showed it helped reduce medical costs.
However, significant issues have recently surfaced. The problem is that there is no FDA surveillance system in place to effectively monitor quality after devices are approved.
To its credit, the FDA has acknowledged the problem and is working to address it by developing a guidance document for manufacturers and strengthening current standards, Kahn said.
"However, while the FDA works to address the problem, these inaccurate monitors are still commercially available, and as of July 1, these inaccurate monitors will very likely come out ahead under the new Medicare competitive bidding program," Kahn wrote.
"With competitive bidding, products are assumed to be of equal quality and accuracy, and bids are based on cost. In efforts to reduce the cost of care, we will likely also be reducing the quality of care by providing our nation's diabetics with inaccurate technology."
Congress and the CMS must rethink the new competitive bidding program, Kahn advised.
"Over the long term, I have great confidence that the FDA will act in the best interest of patients and put stringent post-market surveillance in place to ensure products continue to meet FDA standards after approval," Kahn said. "In the meantime, anything that will stop the widespread introduction of defective systems into the marketplace is urgently needed."
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