I, like many people who care about people with diabetes, have a real bee in my bonnet about Medicare’s attitude toward diabetes — particularly in reference to its newly implemented national mail-order program for diabetic supplies. So much so that I actually just said “bee in my bonnet,” which I believe is the very first time in my life that I have ever used that expression.
Why, you might ask, is my bonnet so bee-filled? Because the reduced access to high quality blood glucose meters is putting seniors’ lives at risk. Yeah, that’s right: if you love anyone who’s got diabetes and is over 65, the unintended consequences of this program could kill them. Here’s the issue in a nutshell:
1. On July 1, 2013, Medicare implemented a mail order program for diabetes testing supplies nationwide. Translation: If you’re on Medicare and you want to get your diabetes test strips by mail, then you must use a Medicare-approved supplier for those test strips. (Important note: if you don’t mind going to the pharmacy, you can get your strips from a Medicare-contracted pharmacy — but it may end up costing you more, and is also obviously less convenient.)
2. Medicare only gave contracts to about 2 dozen suppliers (not all of which are available in all geographic areas, so your choice of where to get your test strips is limited). Perhaps even more importantly, it reduced the reimbursement rate for diabetic test strips by about 72 percent. This was meant, obviously, to reduce costs. But this rate was so low that it can’t pay for strips from some of the big test strip makers — like Abbott, Roche and Accu-chek. As a result, suppliers are switching many Medicare recipients — often against their will — to generic meters and strips instead. (Really important note: They’re not allowed to do this! If you’re on Medicare, you have the right to stay on the meter prescribed by your healthcare professional. For more details, scroll down a bit on this page.)
3. Blood glucose meters are not interchangeable. This is partly because different people — particularly seniors — have different needs (for example, you might need a meter with large type, or a meter that speaks to you in case you have poor eyesight and can’t see the number, or a meter that is particularly large or small, etc), and partly because . . .
4. . . . Diabetes test strips and blood glucose meters are not all equally accurate. This might come as a surprise to many people — I for one had previously assumed that a meter is a meter is a meter — but there are many meters on the market that do not consistently give accurate results, and generic meters, particularly those produced overseas, are particularly problematic. (Read my article, Why You Should Worry About the Accuracy of Your Blood Glucose Strips, for more information — as well as my post, Why You Should Be Depressed About the Government’s Attitude Toward Diabetes.) Guess which meters the Medicare-approved suppliers are pushing on seniors? The cheapest ones possible — i.e. the very generic meters that are the most likely to be inaccurate. What’s more, there is also no program in place to make sure that meters and strips that get cleared by the FDA continue to maintain the same levels of accuracy once they’re on the market. (For more on this issue, check out StripSafely.com.)
The dangers posed by inaccurate meters and strips should be obvious: if you use a meter to dose insulin, and if your meter is wrong, then you can take too much insulin — and you could die. Senior citizens need access to accurate blood glucose meters. (As do ALL people with diabetes!) This is not a push for a particular brand or company — if we can get accurate meters for less money, that is great. But cost reduction should not threaten the lives of the very people it’s meant to help.
I’m going to write an article about the American Association of Diabetes Educators’ recent investigation of the competitive bidding program for diabetic testing supplies (spoiler alert: suppliers are not providing what they promised). But for now, I bring the subject up because Manny Hernandez of the Diabetes Hands Foundation/TuDiabetes just tweeted an article that I very much hope the powers that be at the Centers for Medicare and Medicaid Services (CMS) pay attention to: an article from US News and World Report titled “Elderly Diabetic Patients on Insulin Most Vulnerable to Low-Blood-Sugar Trouble.” If I may quote:
“A new look at diabetes patients in the United States who use insulin and wind up in the emergency room with low blood sugar shows the dangerous scenario is more than twice as likely to happen to those over 80 years old.
“Not only that, elderly diabetes patients are five times more likely to be hospitalized than younger patients as a result of the low-blood-sugar episode, the study found.
“‘Managing insulin can be a complex endeavor,’ said study author Dr. Andrew Geller, a medical officer at the U.S. Centers for Disease Control and Prevention. ‘We knew it would cause a lot of emergency-department visits for adverse events, but we didn’t expect the full severity of these events. Almost two-thirds involved things like passing out and seizures.'”
Geller and his colleagues “were able to estimate that just less than 98,000 emergency-room visits occur in the United States each year due to insulin-related low blood sugar,” and that “almost 30 percent of those emergency-room visits resulted in hospitalization.”
Putting aside the obvious health risks posed by severe hypoglycemia, I’d note that 98,000 emergency room visits per year likely cost the government (and health insurers) a hell of a lot more than the price of an adequate supply of accurate blood glucose meters and strips.
Judging from comments I heard from CMS at the Diabetes Technology Society’s meeting in September, however, I anticipate that CMS would interpret the findings of this study quite differently — namely, they’ll see it as evidence not that blood glucose meters need to be accurate, but that fewer seniors should be on insulin.
What this interpretation would miss is that these are two separate issues. We in the diabetes community are not talking about whether a senior citizen should or should not be on insulin. That is a choice that should be left to the person and his or her doctor. What the diabetes community is saying is that a blood glucose meter is only a blood glucose meter if it is accurate. If it is not accurate, then it cannot be used to dose insulin or “make therapy adjustments,” if I may quote CMS itself. And if a meter cannot be used to “make therapy adjustments,” then it cannot be considered to be Durable Medical Equipment (DME) and therefore cannot legally be covered by Medicare.
If you think this issue is important and would like your voice heard, here’s some good news: the FDA is accepting (and encouraging) comments from the public on its new draft guidance for blood glucose meters. (FDA is not responsible for competitive bidding — in fact, the FDA appears to have quite an enlightened view toward diabetes devices — but since CMS often looks to FDA guidance to make decisions, it’s important for us to make our concerns and suggestions known to the FDA.) Check out the sample comments the StripSafely team and I put together — complete with easy-to-follow instructions and links — here. (Pay particular attention to the suggested comments about “durable medical equipment,” since that is the part most likely to impact CMS and the coverage issues brought up in this post.)
I also recommend that you consider sending a letter in support of calling a Congressional hearing to ensure that the meters provided under Medicare’s competitive bidding program live up to the accuracy standards of the FDA. We’ve put together a sample letter — again, with instructions — here. It’s really easy, and could make an enormous difference.
Lastly, if you or your loved ones experience any sort of adverse effect of Medicare’s policy toward diabetic testing equipment — whether it’s a problem with the meter or test strips themselves, or a problem getting access to them to begin with — I strongly encourage you to complain directly to CMS. You can do so via this link. Heck, I recommend filing a complaint regardless, pointing out the issues raised here and on StripSafely.com. And while you’re at it, why not contact the Inspector General of Health and Human Services, the government agency responsible for investigating Medicare Fraud. Point out that if Medicare is reimbursing suppliers for testing equipment that can’t be used to make therapy adjustments — and that therefore cannot be considered to be Durable Medical Equipment — then those suppliers are defrauding the government by receiving reimbursements for equipment that should not technically have been covered. (More on this line of thought later.)
If you tweet this article, or anything about it, please use @medicaregov and @OIGatHHS (the inspector general) so that they are aware of our concerns. And if you can throw in a little @stripsafely as well, that would be superb.
Thank you for reading this. If we work together, we may be able to save people’s lives.