CGM Trial/Appeal Letter

Type 1 Diabetes Awareness

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CGM Trial

I wanted to document our Dexcom Seven Plus CGM trial.  The reason the endo ordered it is due to hypo unawareness. After this trial was completed, we fought the insurance company and he got his own CGM even after them telling us there was no way they’d pay for it.

Day 1

Got the Dexcom Seven Plus put on by the Dexcom rep at the endo’s office.  He gave us a brochure and said to come back in a week.  He was very nice but didn’t really explain much so we were left to find all the information out on our own.  What does the arrow mean, can we see the last alert, is calibrating more often mean better accuracy?  So many questions. 

Day 2

Things are going ok, still don’t know very much about this I feel maybe we should of been given some type of crash course even if it was only for 7 days.  I know the arrows go up, down, right, and at an angle but don’t know the rise or fall rate yet.  He doesn’t feel the sensor in his body.  I’ve noticed that there will be gaps in the data on the Dexcom screen, I found out that means it wasn’t picking up the sensor.  Sometimes there is gaps and the monitor is right next to him without anything blocking the sensor.  Maybe that happens in all the CGM’s?

Day 3

I like the CGM so far and it does give peace of mind eventhough its not 100% accurate.  So far the biggest variance was 34 points.  The CGM was reading 192 but his finger stick was 158.  So I was thinking, what is the point of wearing this CGM if we are not keeping any type of records, I thought that would be a good idea but nobody at the endo’s office nor the Dex rep told us to do that so I called the endo’s office and asked.  She said “Didn’t anyone tell you to do that?”  I replied no, because the only people in the room was HER and the Dexom rep so I’m not sure how she forgot to mention this important step.  Then she blamed it on the Dexcom rep saying that she should of told us to keep records (but I don’t think that’s right I think its the responsbility of the doctor’s office).  She then went on to say that “most people” don’t want to keep records but if we “want” to we can.  (What in the world??!!  Why would you wear this amazing device and not keep records, that is the POINT of this device, to get better control and to give the doctor all the information possible so they can help.)  She also said most people don’t even check their blood sugars when they should.  Well, that may be the case for “most or some” people so does that mean she gave up being a good nurse too?  Does that mean she doesn’t have to give us the accurate information, because it seems she just lumped us in with “most or some” people that don’t “want” to do it.  (Ok sorry for the rant, that was just upsetting.)  Anyway, at least we are keeping records now.  Maybe we should of known that but we aren’t the medical professionals here and this was the first time wearing this CGM.

Days 4 – 6 

Days 4 – 6 were the same, still had questions but I realized we would not figure out all there is to know about the CGM unless he has one himself.  I guess its kinda like the insulin pump, it takes a while to get to know everything.  We noticed the readings varied throughout this 7 day trial even though he calibrated it as recommended, sometimes the readings were way off and sometimes not so much (when compared to a finger stick) BUT we now know the #1 benefit to the CGM is the trends, which can be a AMAZING tool and help in BG management.

Day 7 

Returned the CGM and they said they will gather all the data and give it to us on the next visit.   

CGM Appeal Letter to Insurance for Dexcom CGM

*Tailor the letter to you if something stated does not fit

Date

Health Insurance Company Name

Patient Name

Patient Date of Birth

To Whom It May Concern:

I, Patient Name, am requesting coverage of a continuous glucose monitoring system for durable medical equipment A9276 sensor, A9277 transmitter and A9278 receiver.  (Check with Dexcom that the listed codes are still current).

I have been Type 1 insulin dependent diabetic for the last xx years and even with checking my blood sugar xx times a day I still find it very difficult to get good control. I have also completed diabetes self-management education so I am trying all I can to get good control and at this point I need the CGM more than ever.  I have a history of wide fluctuations in my blood sugar with severe hypoglycemia as well as hypoglycemia unawareness.  My HbA1c values have improved immensely to xx% since approval of my insulin pump on (provide date) but I still deal with drastic swings in my blood sugars.  With the wide swings in my blood glucose levels it appears as though I have good control since my most recent HbA1c was xx% yet the wide swings actually balance it out to a good average HbA1c but that does not mean I have good control.  In a letter provided with this packet my endocrinologist, Dr. Doctor states although my HbA1C is xx% I have severe fluctuations in my blood sugars and a CGMS would be ideal to help prevent extreme highs and extreme lows from occurring and prevent long-term complications from recurrent severe hypoglycemia.

I have reduced my insulin dosage to help prevent my hypoglycemic episodes but they still occur frequently.  I have also provided my insulin pump setting reports with this packet to show I have reduced my insulin.  My girlfriend/boyfriend/husband/wife/etc, Name, has had to assist me in treating my low blood sugars on several occasions because I don’t even feel I’m low but he/she recognizes it and gives me glucose drink or glucose tabs. I usually work late (or while at school) and have gone low at work (or school) but have not realized it and it wasn’t until I got home and my xx realized something was wrong and helped me as he/she always does. In the past my blood sugars have ranged from xx to over xxx and are very inconsistent. In the past I have also been hospitalized on several occasions for Diabetic Ketoacidosis (DKA). I have severe hypoglycemia unawareness and do not feel lows at all. With my severe hypoglycemia, I am afraid of going too low which could cause detrimental consequences for myself and my family.  I am consistently low and have severe hypoglycemia both during the day and while I’m sleeping.  My xx actually stays up and checks my blood sugar in the middle of the night while I’m sleeping, if it is low he/she will wake me up and treat me with fast acting carbohydrates, as mentioned earlier with glucose drink or glucose tabs. If it is high he/she will give me insulin via my pump.  Since my hypo unawareness can occur at any time it scares me because again I don’t recognize my lows.  What if xx was not there?  He/she is the only person that lives with me (or I live alone).

I also experience regular postmeal spikes and I often do not realize I’m high until I get tired and sometimes confused. I always keep my endocrinologist office informed and are working with them. My endocrinologist, Name of Endo, said this CGM can help me achieve better control and lessen the blood sugar swings because I will be alerted by an alarm on the CGM and be able fix the oncoming high or low before it happens. I check my blood sugars regularly every day and I make adjustments to my insulin dosage and take advantage of the combo bolus feature on my insulin pump to get the perfect ratios but I still can not get good control. It’s a constant balancing act. I have made several adjustments to my insulin dosage.  I have tried changing my insulin to carb ratios as well as changing my basal rates, with assistance from my endocrinologist office and I still have the wide fluctuations in my blood sugar.

“High and low glucose limits our ability to focus, remember, perform complex tasks, and be creative. Research studies have repeatedly and consistently shown that as blood sugars go up, so do mental errors and the time it takes to perform basic tasks. Wide variations in blood sugar levels, such as postmeal spikes, have also been shown to hinder intellectual function.  Likewise, if glucose levels are too low (typically below 55 mg/dl), the entire nervous system lacks the fuel it needs to operate correctly. So, if you want to perform as well as possible at work or in school, watch those sugar levels.”  (excerpted from the book – Think Like a Pancreas by Gary Scheiner, MS, CDE – updated version – pg. 16-17.)

Major long-term multicenter research projects such as the Diabetes Control and Complications Trial (DCCT) have proven beyond a reasonable doubt that tight glucose control does make a difference.  Minimizing glucose variability (dramatic swings into high and low glucose ranges as I experience) is believed to have a stabilizing effect on blood vessels and the organs they nourish. Tightening blood glucose control also reduces the risk of kidney disease. When I was hospitalized for DKA my liver was swollen and the lining of my kidneys was beginning to deposit into my urine. (Put an experience you have had.)

Blood sugar levels have a direct effect on mental well-being.  People with diabetes are more prone to depression and in (year) I was diagnosed with depression by my primary care physician, Dr. Doctor.  Having a CGM can help stabilize my blood sugar levels therefore help my depression as well.

 I am very attentive to details in regards to my compliance with my diabetes.  I do everything I possibly can to keep under the best control but am up against a lot and need the CGM to get optimal control.  I need the continuous glucose monitor in order to live without the fear of hypoglycemia.  I need the system to keep my job performance at its best and provide for myself and my loved one. (or I need the system to perform well in school etc.)

I have come across many people that are not familiar with my situation and while I have an insulin pump, I want to make sure people understand it is not fully automated and I have to adjust the settings myself and with my wide fluctuations it is not easy.  The CGM would automatically check my levels every 5 minutes and alert me when I’m too high or too low.  If I were to check my blood sugar every 5 minutes I could not live a normal life plus I could not afford to pay for extra test strips.

There is nothing I could of done to prevent my disease and there is no cure. The above CGM device is medically necessary for me based on my medical history. One severe hypoglycemic event is enough for anyone with Type 1 Diabetes let alone several.  Please cover the Dexcom Continuous Glucose System so I can live a safe, healthy and productive life despite having type 1 diabetes.

If this appeal is denied I would like to request an external appeal because I desperately need this medical device, my endocrinologist said I was an ideal candidate for it, and it could save my life.

Sincerely,

Patient Name

The Dexcom CGM is an FDA-approved device, worn by patients with diabetes, that records glucose levels throughout the day and night and provides continuous “real-time” readings and data about trends in glucose levels. While standard fingerstick measurements record a person’s glucose level as a snapshot in time, the Dexcom CGM measures glucose levels every five minutes, 24 hours a day. Both physician and patient use this additional information to detect trends and track patterns in glucose levels on a daily, weekly and monthly basis and then use this information to take corrective action.  As you can see, it is impossible to capture this type of information by fingerstick measurements alone.

The Dexcom CGM helps to detect when glucose levels are dropping and when glucose levels are rising in-between meals and helps to indicate how exercise and diet might affect glucose levels.  Monitoring during periods when blood glucose levels are not typically checked (e.g. overnight) can help to identify problems in insulin dosing (such as basal levels for insulin pump users or long-acting insulin levels for patients taking injections), predawn phenomena or nocturnal hypoglycemia. The Dexcom CGM is equipped with alarms to alert patients of hyperglycemia or hypoglycemia so that a patient can take immediate corrective action(s) even in cases when they do not feel symptoms of this condition.

Therefore, with the use of the Dexcom CGM, the patient will be alerted before going low in order to prevent hypoglycemic reactions. Additionally, the DexCom CGM will allow for detection of unexplained post meal hyperglycemia so they can make immediate therapeutic modifications. By early detection of both hypo and hyperglycemia, the Dexcom CGM will help to alleviate the wide glucose excursions that they are experiencing and assist in attaining and maintaining euglycemia.  As you are well aware, this will minimize/alleviate the acute and long-term devastating complications of diabetes.

ECRI Institute, an evidence based practice center, “believes that under close clinical supervision—preferably by a board-certified endocrinologist—use of a real-time continuous glucose monitor may benefit select individuals with diabetes to track trends and patterns in glucose levels or assist the provider in unique situations when additional information is needed. This information can then be used to adjust diabetes management. These select situations include the following:

  • When hypoglycemia occurs without symptoms (hypoglycemia unawareness)
  • When nocturnal hypoglycemia is suspected
  • When hypoglycemic and hyperglycemic events are refractory to multiple adjustments in self-monitoring of blood glucose and insulin administration
  • When large fluctuations occur in before-meal glucose values
  • When starting insulin for the first time
  • When starting on an insulin pump regimen”

As you can see from the clinical information provided above, my medical condition meets several indications listed and therefore I am an appropriate candidate for the Dexcom Continuous Glucose Monitoring System.

The features of the continuous glucose monitoring system clearly allows for people with diabetes and their physicians to track and analyze day-to-day changes in glucose levels due to diet, exercise, medication, and lifestyle and make appropriate therapeutic modifications. This CGM can result in better glucose management, fewer incidents of hypoglycemia, fewer emergency room visits, fewer hospitalizations, and improved quality of life.  These results are in line with the DCCT study analysis of 1993, which demonstrated the outcomes of aggressive glycemic control.  Aggressive glycemic control without the complications of hypoglycemia has not always been possible until the advent of this improved glucose monitoring technology. Continuous glucose monitoring is becoming the preferred technology for supplying information and feedback that is proving to be beneficial in the guidance of treatment and lifestyle interventions for persons with diabetes.

Additional Information

  • Have your endocrinologist write a letter of medical necessity and keep one for your records and send one with the appeal.  If it is medically necessary for you to have a CGM, make sure the doctor uses those words in the letter, “medically necessary”.  If the patient has hypoglycemia unawareness, make sure the endocrinologist writes that in the letter and explains the seriousness of someone being hypoglycemic unaware.
  • The insurance company sent us a letter as to why the CGM was originally denied.  The reason they stated was because he did not make any adjustments in his insulin, which was a complete lie because he did.  I have no idea where they even got that from, his endocrinologist did not say that so I copied that original denial letter and sent it back with a star next to where it said he didn’t make adjustments in his insulin and stated that was not true and the endocrinologist confirmed this in the letter they wrote.
  • Send in pump reports or logs showing you’ve made adjustments.
  • Remember that appealing doesn’t necessarily mean you have to go in for a hearing somewhere, for us all it meant was sending documentation through the mail and a few phone calls.