No True Government Support for Test Strip Safety

This is a take off on Ann Bartlett's blog of July 17. I have held this too long, but with what has happened with the Society of General Internal Medicine (SGIM) and their list for Choosing Wisely, I feel that this needs exposure again. Ann is very confident that our medical insurance needs to stay out of the way when it comes to our medical supplies.


Unfortunately, they will be hitting type 2 patients on oral medication very hard probably around the first of the year. When Dr. Robert Ratner, chief scientific and medical officer for the ADA that says, “Many people with type 2 diabetes who are on medications don't need to do home glucose monitoring at all." This is followed by the SGIM putting this statement at the top of their “Choosing Wisely” list, "Don't recommend daily home finger glucose testing in patients with Type 2 diabetes mellitus not using insulin,” patients with type 2 diabetes on oral medication will be in the dark about the management of diabetes. Yes, bold is my emphasis, but apparently is having little in the way of getting people upset.


Our local support groups have had a meeting about this including a support group from a neighboring community. I appreciate the action of the support group I belong to for their actions, but for other emails, I have only had one from a doctor that I have had discussions with and worked with on setting up shared medical appointments. See my blog here.


David Klonoff, MD, from the University of California, San Francisco had the only positive comments at the meeting held the week of September 9. He also said, "Our organization is very interested in this public-health issue, which is to see that safe blood glucose monitoring systems are available for patients." Yes, some of the representatives from the online diabetes community were positive, but only about the desire to promote test strip safety and reliance.


Even the FDA was dragging their feet to delay action. Yes, you can claim that it takes time for them to act, but without funds to back up the request for action, the FDA will continue to side step on the issue time after time.


Courtney H. Lias, PhD, director of the division of chemistry and toxicology devices at the FDA, said, “Some advantages of a surveillance system include its potential ability to identify sources of error for further investigation and to deter/discourage detrimental manufacturing or design issues.” She continued, “However, some of the downsides are that such a system won't identify the source of the error — additional investigation would be required; it might be expensive and difficult to oversee; and small sample sizes might not detect outliers among the billions of glucose tests conducted every year.”


Translation, It isn't going to happen. This is confirmed by her statement, “And to make such a program mandatory, either Congress would have to pass a new law or the FDA would have to engage the rule making process, which is typically incredibly lengthy and, at best, takes 5 to 6 years. "This is not an overnight scenario."”


So between the FDA and CMS, we can forget about increased accuracy or correcting problems in the supply of faulty test strips. Yes, the FDA will support a voluntary program that requires no funds from them. However, the program must be a credible surveillance program and if it is, it can be a very powerful tool. (If the FDA chooses to back it.) Surprisingly the members of most manufacturers in attendance endorsed to proposal.

 
CMS does not agree.

More Debate on Test Strip Accuracy

This is about what I expected, age discrimination by the Centers for Medicare and Medicaid Services (CMS). CMS's Dr. Elizabeth A. Koller made that perfectly clear. Have no doubt, she will carry this forward and make sure her discrimination will happen. To quote what she suggested, “That glucose test accuracy standards might not need to be as stringent for many Medicare beneficiaries, most of whom have type 2 diabetes, because the evidence is lacking for a clear benefit from intensive glycemic control in this type of diabetes.


This is why test strips are so limited for Medicare beneficiaries to prevent evidence from being collected to disprove her statement. This is why NIH and other government sponsored research does not include senior citizens. They want to treat us as second-class citizens not deserving to be considered as being able to manage our diabetes. According to other statements, Medicare beneficiaries have too many other comorbidities to accurately assess how effective wasting money on us can benefit us. Discrimination is the accurate term for how Medicare beneficiaries are treated and thought about to diminish our worth.


Granted Dr. Koller later limited her comments to type 2 patients who don't use insulin; however, don't think she did not mean all type 2 patients and type 1 patients. If you can't believe this, then why did she take to the tack on cardiovascular disease stating that aggressive glucose control does not mitigate the CVD risk? This alone confirms she is talking about all patients with diabetes, on insulin or oral medications.


Then she seals this with the kiss of death when she says, "The goals and what is needed by our population may not be appropriate for what is needed for other populations.... In addition, there are actuarial considerations for our population, issues of expected lifespan and the burden of comorbid disease."


Then she tries to say that Medicare is particularly concerned about the avoidance of hypoglycemia among its beneficiaries. Oh, really? Then why does Medicare strictly limit testing supplies for all type 2. One test strip is not very valuable for people taking sulfonylureas when they have hypoglycemia. Three test strips for type 1 and type 2 on insulin is not very valuable for hypoglycemia when it may be necessary to test 5 to 8 times to bring hypoglycemia under management. No, Medicare DOES NOT CARE. Presently their only interest is in cutting corners at the expense of the Medicare beneficiaries.


The final concern is expressed by Gary A. Puckrein, PHD when he says, "Using the word 'actuarial table' to refer to diabetes patients is scary. He noted that glycemic control among minority populations with diabetes is exceptionally poor, and we need to get them under control. Medicare is government social insurance and has no right to pick winners wherever they are in the system."


Dr. Koller has carefully positioned the CMS to continue business as usual and made no statements that conflict with this. To this I say – Give us back out test strips!