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Medicare Bidding Program Puts Diabetic Patients in Danger
Date:7/11/2013

d 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."

Moreover, Kahn said 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," he wrote, adding that beneficiaries are assuming that under the CMS bidding program there will be equal quality and accuracy.

"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," Kahn warned.

"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."

The quality of the new equipment isn't the only problem.  Medicare paperwork requirements are forcing patients to return to their doctors for new prescriptions, which may force patients to bear the cost of another copay.

"Consumers who contact a bid winning provider find out they need to get a new prescription from their doctor for the new provider, whic
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SOURCE American Association for Homecare
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