The National Diabetes Volunteer Leadership Council (an organization comprised of former chairs of the board and past officers of the American Diabetes Association) is calling on Congress to convene an oversight hearing to ensure that all blood glucose meters provided to Americans under Medicare’s current competitive bidding system meet the accuracy standards established by FDA Clearance guidelines. Please join us by writing or calling your elected officials and asking them to help people with diabetes to StripSafely.
Find your Senators and Representative at this site: http://www.usa.gov/Contact/Elected.shtml
From that site you can find their webpages and DC and local offices.
Mail to Congress in DC is slow due to security, so we suggest submitting your letter by email if possible. Consider sending to both the DC and local office. Here is a sample letter you can send.
Dear [Representative Last Name],
My name is [First Name Last Name], a resident of [City, State]. [One short sentence on who in your life has diabetes and how long they have had it.] I seek your support on an issue that has the potential to harm [me/my loved one] along with the 26 million Americans living with diabetes, but one that you have the power to change. I am joining with the National Diabetes Volunteer Leadership Council (an organization comprised of former chairs of the board and past officers of the American Diabetes Association) in asking you to call to order a Congressional oversight hearing to ensure that (1) all blood glucose meters that are provided to Americans through the Centers for Medicare and Medicaid Services’ (CMS) current competitive bidding system meet the accuracy standards established by the FDA, and (2) that CMS requires its contract suppliers to continue to provide adequate supplies of the brands of meters and strips included in their accepted bid. The health and lives of many of your constituents are at stake.
As you may know, people with diabetes use blood glucose meters and test strips to decide how much insulin to take, often more than three times per day. What many people don’t realize, however, is insulin is an extremely dangerous drug, potentially fatal. Even taking slightly more insulin than necessary can cause confusion, disorientation, even seizures and unconsciousness — all of which explain why insulin is one of the most common reasons that Americans over 65 are admitted to the emergency room. [http://www.drugs.com/news/adverse-reactions-new-national-perspective-risk-1954.html] For this reason, CMS should require that all blood glucose meters covered under competitive bidding meet the FDA’s standards for accuracy — both before and after they come to market. Allowing substandard meters to be covered under competitive bidding as Durable Medical Equipment puts Americans’ lives at risk.
This may sound like a no-brainer — of course the devices used to determine the doses of a potentially deadly drug should be accurate — but unfortunately, major problems exist. Three recent independent laboratory studies call into question the accuracy of the blood glucose meters and test strips that people with diabetes, like [my daughter/myself/my father/etc.] need to stay healthy. Indeed, in a recent clearance document, the issue of meter accuracy was confirmed by the FDA itself. And at the moment, there is no post-market surveillance program in place to ensure that meters and test strips continue to meet the FDA’s required standards for accuracy once these products are on the market.
Second, the Competitive Bidding Program was established to reduce additional costs to Medicare caused by fraud and overbilling for medical supplies, like walkers, that are functionally equivalent. (For example, standard power wheelchairs are included under Competitive Bidding, but personalized power wheelchairs are not.)
However, blood glucose meters and test strips are not all functionally equivalent. Not only are there discrepancies in accuracy, as indicated above, but different meters offer different features. For example, some meters communicate directly with insulin pumps; others have features for specific patient populations, such as “talking” meters and meters with large displays for people who are visually impaired. (These are especially important, given that impaired vision is a known complication of diabetes, especially in the Medicare population.) Medicare beneficiaries must have access to the exact meters and strips specified by their doctors.
Unfortunately, there is currently no requirement in place to ensure that the contract suppliers that are offered contracts under competitive bidding continue to stock adequate supplies of the meters and strips they listed in their bids. A recent study by the American Association of Diabetes Educators found that of 23 surveyed suppliers, none were offering products reflecting greater than 50% of the market, as intended by Congress, and only three (3) of the 23 suppliers carried each brand of diabetes testing supplies that they reported carrying to Medicare. What’s more, Medicare’s own website reflected inaccurate information about coverage. This is unacceptable.
To ensure the safety of its constituents, Medicare must only provide DME coverage for meters and strips that meet FDA standards for accuracy, both pre- and post-market. It must also ensure that suppliers that are awarded Medicare contracts actually provide the brands of meters and test strips that they promised in their initial bid.
Solutions: The FDA and Diabetes Technology Society (DTS) have proposed independent processes for post-market inspection of meters systems to make sure they continue to meet the accuracy standards required by the FDA after they come to market. AADE has provided recommendations for how Medicare can ensure that its constituents have access to the specific meters required for their health. FDA, DTS, AADE and, most significantly, your constituents with diabetes need your support and oversight to make these programs successful.
[Representative Last Name], in order to be a leader on this safety issue, I ask that you work to create Congressional oversight over the recently rolled out Medicare competitive bidding program for durable medical products. Intended to reduce healthcare costs, it was a good idea in theory. But reality has exposed significant and dangerous issues – especially when it comes to diabetes care. As a result, the lives of many of your constituents could be at stake.
[Your First and Last Name]