A Slice of Life with Diabetes

A COMMENT REGARDING CMS RULING ON DEXCOM G5 By Dan Patrick

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The impetus of this comment is the notice from the Food and Drug Administration, FDA, about the Dexcom G5 Mobile Continuous Glucose Monitoring System, (CGM), P120005/S041, with an approval date of December 20, 2016. On January 12, 2017, the Department of Health and Human Services and the Centers for Medicare & Medicaid Services, CMS, issued Ruling No.: |CMS-1682-R|. This CMS ruling articulates CMS policy concerning the classification of continuous glucose monitoring systems as durable medical equipment under Part B of the Medicare program and declared that CGM can be used without confirmatory blood glucose strips. What was interesting to note was the fact of the coordinated releases from FDA and CMS. From my personal viewpoint of fifty plus years as a type 1 diabetic and a current Medicare individual, I view this new ruling with some trepidation.

The real dilemma is based on the fact that when the discussion of diabetes is raised, there is a lack of consideration of the various levels of configuration of medical equipment to manage this condition. A singular decision regarding a singular piece of equipment can result in multiple and conflicting rulings by multiple parties in the United States Health Care System by favoring one set of choices. The case can be made that our health care has come down to a single review of what is the cheapest in the short run with no consideration or potential effects in the long run.

Does it make any sense to have price as the only criterion?

In both of the decisions listed above, there is an attempt to reduce overall costs by reducing the number of blood glucose readings. Precision and accuracy are highly critical factors that have been ignored when discussing blood glucose stripes. For example:

  1. What are the number and percentage of failures of blood glucose stripes per box?
  2. Meaning they do not work at all. Human errors are another. One example in the testing process too little blood was applied to the stripe.
  3. What is the accuracy of the blood glucose stripes at a range of blood glucose levels? How accurate are blood glucose stripes from 40 mg/dL through 400 mg/dL both in percentage and numeric values of mg/dL?

An excellent article on this important matter can be found on the Integrated Diabetes Services site article entitled; “Choose Your Blood Glucose Meter Wisely”. The successful utilization of a CGM requires calibration. Improvement in blood glucose accuracy cannot be underestimated. CGM Calibration should be the most accurate value available.

Does a Continuous Glucose Monitoring System need to be calibrated?

  1. The FDA article states: The (Dexcom-CGM) must be calibrated at least two times per day by testing fingertip blood samples with a blood glucose meter.
  2. Events can happen which send blood glucose and interstitial glucose readings in fast and unplanned opposite directions which can be too high or too low. One example is an insulin pump inset that moves and causes a wound to form at the inset location.
  3. This can require an inset change and there are times when a CGM sensor stops functioning. It is obvious that there is no thought or discussion of failure of any of the equipment utilized by diabetics to manage our condition. They can stop working! The FDA article refers to them as adverse events.
  4. Calibration sets the reference point for a CGM. This requires a blood glucose meter with stripes. When a CGM sensor is changed, that particular day could require a minimum of three stripes every six or seven days. Two stripes per day should not become an absolute.

It is interesting to note that Medicare has a habit of changing the warranty period as defined in the FDA rulings.  Page 6 of the CMS ruling states: “Once the coating wears off in 6 or 7 days, the sensor must be replaced for safety reasons”. It is interesting to note the difference of referring to monthly purchases verses a 28 day cycle purchase for four seven day sensors based upon the safety factor. Stay consistent and uniform with definitions. Ordering should be by the count of the number of days and not on a per month basis. A twenty-eight day cycle would only work in a non-leap year for one month only! It would be helpful if the two organization, the FDA and Medicare got together and maintained clear consistent language for all parties.

 

What are the THREE major variables which are important in the management of diabetes?

It has always been Exercise, Diet and Insulin. I found it interesting to note that the Medicare ruling has no focus on Exercise. The exercise patterns of a five year old, a thirty-six year old, and a sixty-seven year old Type 1 diabetic are totally different.

Correspondingly, the management of the insulin flow and the energy demands on body glucose levels can have a profound impact on the management of our activities. The glucose point of a severe hypoglycemic and the development of hypoglycemic unawareness can be different as well. All diabetics desire a life that minimizes the demands on the management of this condition. Exercise is the point of the day that requires a greater diligent focus on blood glucose levels. The converse point is when we consume food. The depth, breath, and speed of a blood glucose rise or fall is another point which can be assisted by the use of blood glucose monitoring with blood glucose stripes. These are times when interstitial and blood glucose are different in measureable amounts. As a Medicare senior, I have continuously been informed, reminded, and strongly advised to exercise. I do, and it requires that my blood glucose basil flow be reduced by 90% during such periods. This is the time that I really need both my blood glucose meter and my CGM.

How many choices does a diabetic have when attempting to respond to falling glucose levels approaching a hypoglycemic event as signaled by a CGM during the day?

  1. Reduce or stop insulin flow to the body.
  2. Reduce or stop exercising.
  3. Eat a set amount of carbs to raise blood glucose quickly.
  4. Reduce or stop insulin flow and reduce or stop exercising.
  5. Reduce or stop insulin flow and eat a set amount of carbs.
  6. Reduce or stop exercising and eat a set amount of carbs.
  7. Reduce or stop insulin flow, reduce or stop exercising, and eat a set amount of carbs.
  8. Do nothing and hope the falling glucose trend levels come to a steady state within a safe range.

How many choices does a diabetic have when attempting to respond to falling glucose levels approaching a hypoglycemic event as signaled by a CGM during a sleeping period?

  1. Reduce or stop insulin flow to the body.
  2. Eat a set amount of carbs to raise blood glucose quickly.
  3. Do nothing and hope the falling glucose trend levels come to a steady state within a safe range.

It was interesting to note that the FDA discussion had no mention of an exercise factor.

I have found it to be very helpful to have a CGM and a blood glucose meter during exercise periods. The outstanding strength is the sleep period for a CGM. The increase in the variability as listed above necessitate the assistance of a blood glucose meter with strips!

The Medicare Policy does not have a safety value release.

There was a considerable discussion in this Medicare ruling regarding durable medical equipment (DME). What was obvious to me was the fact that the DME policy was changed after January 1, 2012. The DME now has an expected life of at least three years. It is interesting to note that much of the equipment listed is equipment which is outside the body of the patient. It provides a needed assistance to the person. It is my recommendation that DME policy be modified to include an exceptional consideration clause item which could be approved for less than three years. Why should we wait for a possible technical improvements before adoption?

Finally, what must be taken into consideration is the fact that the body is not a machine, and there are a whole host of variables that can come into play which will have an impact on our blood glucose and interstitial glucose levels. There are many that we do not have the tools to measure and record! One factor is age and another is hypoglycemic unawareness. It is my position that the above policy needs work. Medicare needs to give consideration for initiating public comment periods on proposed policy changes. Diabetics desire a life that minimizes the demands on the management of this condition and are best focused at the doctor – patient level and not on the compliance factor of numerous Medicare restrictions. This particular CMS Ruling No., CMS-1682-R should not an either or decision regarding blood glucose meters and stripes verses a CGM. We need both at this time. Diabetes is a highly burdensome, 24/7 disease with no time off.

It is my position that having both a Blood glucose meter with strips and CGM comprise a multiple backup system should one of the two units fail for whatever reason.  The coordination of tools should be focused on the best possible outcomes for the individual patient and determined in conjunction with one’s physician.

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