On July 1, Medicare implemented the national rollout of a new competitive bidding program for durable medical products that is intended to reduce health care costs without sacrificing quality. Indeed, the government ran a pilot program in nine markets, and in that experiment, competitive bidding between medical product manufacturers helped reduce health care costs. Unfortunately, significant issues have recently surfaced that threaten to seriously undermine the ability of the Centers for Medicare & Medicaid Services to deliver quality care at these costs.
The problem is that just as the Medicare train pulled out of the station, we’ve discovered a quality issue with diabetes self-monitoring blood glucose systems that will only be exacerbated by competitive bidding. At a meeting in May, attended by distinguished scientists and Food and Drug Administration representatives, it was openly acknowledged, with much supportive data, that many monitors are not meeting FDA accuracy standards once they’re approved and on the market. Almost all of the problems are with low-cost products manufactured overseas.
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.
So what does this have to do with competitive bidding? 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. 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.
What does this mean for the health of millions of Americans with diabetes on Medicare, many of whom rely on these glucose monitors to keep their diabetes under control? Many of our most vulnerable citizens will assume the test they use is accurate, adjust their insulin dose accordingly, and could unknowingly be putting themselves at risk of hypoglycemia, hospitalization and even death.
I understand and applaud the motivation to reduce costs. But not when there is a clear and present danger for harm — harm that not only will affect health but will likely cause an increase in costs when inaccurate monitoring systems lead to more physician office visits and hospitalizations.
In the decades I have worked in the field of diabetes, there have been few risks as clear and urgent as this one, and action must be taken.
First and foremost, Congress and the CMS must rethink the new competitive bidding program. 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. In the meantime, anything that will stop the widespread introduction of defective systems into the marketplace is urgently needed.
Dr. Richard Kahn is a professor of medicine at the University of North Carolina and was formerly chief scientific and medical officer of the American Diabetes Association.
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