Food and Drug Administration hasn’t tightened the accuracy standard for blood-glucose meters. Thankfully, today’s models are less susceptible to interference from nonglucose sugars than ever before. Unfortunately, Medicare beneficiaries might not have access to the latest innovations because of cuts in the program’s payments to pharmacies.
A blood-glucose meter is crucial in helping a diabetic to monitor his/her exercise, food and medication several times a day. You would expect that these devices were regulated to be as accurate as possible.
Four years ago, health advocates and endocrinologists asked Food and Drug Administration to tighten its decades-old accuracy requirements, which allow blood-glucose meters—to test blood-sugar levels—to deviate by as much as 20 percent from the result that one would get from a laboratory test. Today, FDA tells us that because of “internal reasons,” it still will be at least another year before it will improve the standard and likely only to a 15 percent variance, says Alberto Gutierrez, who is FDA’s director of Office of In Vitro Diagnostics and Radiological Health.
“It’s taken a lot longer than we would have liked,” Gutierrez says. “This is still an ongoing process.”
A 15 percent variance might sound like an unacceptable variance when you deal with a potential life-and-death matter, such as blood-sugar levels. However, three doctors with whom we spoke, as well as representatives from American Association of Clinical Endocrinologists (AACE) and American Diabetes Association (ADA), tell us that tightening the accuracy requirement to 15 percent will make blood-glucose meters acceptably reliable. In fact, roughly 53 percent of the blood-glucose meters that are on the U.S. market already are within 15 percent variance, and some have a variance of less than 10 percent. The problem is that 47 percent of blood-glucose meters haven’t met the target of 15 percent variance, according to independent studies.
Unfortunately, consumers have no way to tell which ones meet which variance level unless they ask a doctor or have access to independent studies, says Timothy Bailey, who is the director of Advanced Metabolic Care & Research Institute and a member of the board of directors for AACE.
TAKING THE TEST. The major technological change among blood-glucose monitors in the past 4 years took place in test strips. Test strips now distinguish between glucose and other sugars, such as galactose, maltose and xylose. Previously, those nonglucose sugars created interference, or a higher reading than what it should be, in some blood-sugar meters. In turn, that nonglucose interference might lead you to inject a higher insulin dose than is necessary, which could cause coma or even death.
FDA received 13 reports of deaths that were connected to nonglucose interference between 1997 and 2009 but none since then. Six doctors with whom we spoke, as well as AACE and ADA, tell us that the nonglucose-interference problem is solved.
The advances in test-strip technology are a positive step in making blood-glucose meters even more accurate, but consumers who rely on Medicare to pay for their diabetes-testing supplies might not be able to afford the latest test strips.
That’s because the American Taxpayer Relief Act of 2012 includes a provision that requires Centers for Medicare & Medicaid Services (CMS) as of July 1, 2013, to pay retail pharmacies the same price for blood-glucose-meter testing supplies as it pays to mail-order suppliers. The mail-order price is $22.47 for 100 test strips. That’s a far cry from the $77.90 that Medicare pays to pharmacies for 100 test strips. In other words, the price that Medicare will pay per strip will fall to about 22 cents regardless of where you buy. You should keep in mind that the best strips cost at least $1 apiece; strips of acceptable quality cost at least 40 cents each.
CMS didn’t monitor the quality of the products that beneficiaries received when the mail-order program went into effect in January 2011. However, a 2011 American Association of Diabetes Educators study found that after mail-order prices were cut, Medicare beneficiaries had fewer choices and limited access to diabetic-testing supplies, because the mail-order price wasn’t enough to pay for some products. AACE and ADA tell us that they fear that the same thing will happen starting in July 2013 to beneficiaries who use retail pharmacies for their supplies. Patients who rely on Medicare to pay for their testing supplies might not be able to afford the strips that have the best technology, Bailey says.