MEDICARE IS DESTROYING THE LIVES OF DIABETIC MEMBERS

There is a serious, on-going debate about pre-existing conditions and healthcare coverage. The current debate, for the most part, is focused on private healthcare coverage. However, Medicare patients with such conditions are being affected negatively as well. All hell has broken out for me since a mandatory compliance for signup with Medicare and a move to a Medicare Advantage Plan. I have had repeated denials for an insulin choice, blood glucose meter, quantity of strips, and equipment, with numerous appeals.  The entire situation is beyond ridiculous for Medicare diabetics.

Baby boomers born in 1952 are coming through the Medicare portal at a rate of 10,000 new entries every month. The CDC estimates that 1/3 of this monthly flow are diabetics who will be negatively impacted by Medicare restrictions on diabetic care, supplies and equipment as I have been.

I entered the Medicare pipeline in May 2014. At that time, the day-to-day, minute-by-minute personal management of my type 1 diabetes revolved around the functioning of a multiple set of prior approvals, some of which were for durable medical equipment, DME. An insulin pump with components and insulin, a blood glucose meter and strips are examples of a DME. A DME designation is critical in the determination of the payment of claims by Medicare. At one time our choice of insulin for our insulin pump was covered because insulin pumps are a DME.  Now, Medicare dictates the one brand of insulin for our pumps. Medicare will only cover its choice. For 2017, the choice is NovoLog. A doctor-patient choice of either Humalog or Apidra will lose and we will pay more. How does Medicare know our medical history as to which insulin works best for me and every other insulin dependent diabetic?  Again, another Appeal each and every year!!!

I am watching with deep concern the shrinking of the number of Medicare approved insulin pumps, blood glucose meters, blood glucose strips, choices of insulin, and continuous glucose monitors. This is a hidden factor in the loss of competition and firms who are leaving the USA market for diabetes materials. In January 2017, Roche stopped selling Accu-Chek insulin pumps in the USA. My endocrinologist and I spend far too much time with Medicare administrative paperwork rather than the basic doctor-patient relationship with the specifics of my personal condition and data results.

In 2011, Medicare began a competitive bidding program with price as the only criterion. The major component for a functioning insulin pump is the insulin. The original definition for an insulin pump considered insulin as a general term. What complicated the issue of a covered Medicare Medical Part B is the fact that only one insulin product is now approved because of their bidding program. The choice of a fast acting insulin for an insulin pump was reduced from the prior three choices of Humalog, NovoLog and Apidra. Only the winning bidder with the lowest cost would receive the price break on submitted claims for Medicare Medical Part B coverage. This is a substantial financial penalty to the patient. Given that the winning lowest bid may not be next year’s winner raises a serious dilemma. The difficulty for an insulin pump user to change the insulin used in their current pump will necessitate re-calibration of all insulin pump settings. Further, the speed of absorption into the body, the length of time before the insulin becomes effective in lowering blood glucose and the length of time before the insulin expires are just some of the problematic factors. The management plan for meals and insulin to carb ratios will be challenged with an insulin change. The Food and Drug Administration, FDA, singularly approved Humalog, NovoLog and Apidra. They are not identical. Each is uniquely different. The three insulin products listed were developed to expand the choices for insulin. Patients are not alike and historically the choice of only one insulin has failed. A recent article in Diabetes Care validated the fact that such a bidding program has failed on all counts. There is a very interesting coincident. The Medicare competitive bidding program began in 2010. The Wall Street Journal reported in an article by Denise Roland and Peter Loftus entitled, “Insulin Prices Soar While Drugmakers’ Share Stays Flat. The price increases for insulin have more than doubled in price since 2011. Could this, “Medicare competitive bidding program”, be a reason for the increase in costs for diabetics?

Potential, successful research with approval by the FDA facilitates the ability to enter the US market place. How would a new insulin be able to enter the market as an additional optional choice for a doctor-patient treatment when entry is blocked by Medicare? Since the competitive bidding for insulin was started, Apidra has yet to be selected. It is interesting to note that there are healthcare providers with smaller formulary lists which seem to coincide with Medicare approved choices. Again, a restriction spreading into the non-Medicare market is being impacted by Medicare market restrictions. Why is a governmental agency picking winners and losers?

The biggest and most dangerous failure has been the denial by Medicare for coverage in their attempt to block the use of continuous glucose monitors, CGM. Medicare has lost with Local Coverage Articles (A47238) and (A52464).   An appeal which started in 2012 took until late in 2016 after seven different hearings. Do we even know how many successful appeals were granted to cover CGMs via the Medicare Appeal process? The bigger question is the number of severe hypoglycemic event(s) requiring emergency room care for Medicare patients without a CGM.  The prior successful individual Medicare Appeals for CGM coverage have been summarily wiped out via CMS Ruling, CMS-1682-R dated January 12, 2017.

The Medicare Appeal process is an arduous, time-consuming, burdensome five step process. What is the point of asking seniors to enter such a dangerous, complicated maze with the possibility that the successful appeal can be overturned to their detriment? How would you feel after completing a fourteen month successful appeal in October, 2015 to again be faced with the same denial in March, 2016 and January, 2017?

Does CMS-1682-R, after a total loss my life-saving CGM, effective January 12, 2017, have an alternative? NO, NO, NO. They are still attempting to write a policy. Now, how is it that the policy is being written by a Contractor(s) for Medicare? This brings up an interesting question. Are the Contractors compensated for reducing the number of claims by Medicare patients and writing new policies to force additional denial of coverage?

Congress needs to step up and implement a complete oversite review of Medicare. They are not serving the senior population of America.

  1. Have any of you had any opportunity to review a new PROPOSED Medicare Rule before implementation?
  2. The lack of coordination between the Food and Drug Administration, FDA and Medicare is terrible. Why? Medicare in CMS-1682-R has disregarded the warranty period for CGM sensors by overruling the FDA for billing convenience.

On page 6, in the CMS Ruling cms-1682-R; “Once the coating wears off in 6 or 7 days, the sensor must be replaced for safety reasons.”   This is a reference to the FDA decision and is the discussion on the use of sensors which are placed into the body.

How does Medicare coverage for 48 CGM sensors per year equal the warranty safety factor of 52 CGM sensors for an entire year? Cost#!$*#. The four missing sensors represent a shortage of 28 day without warrantied sensors and a denial! Seniors, based upon their age and length of time as a T1d individual have developed a condition referred to a hypoglycemic UNAWARENESS.   What this means is that many have lost the ability to distinguish the start of a serious hypo. Are you cogent during sleep? Insulin is a highly toxic product and has a very narrow safety range for diabetics. What is an interesting fact is that CMS-1682-R only has a focus on insulin dosing and food. What, where, when and how is the impact of Exercise brought into the policy? Is exercise important for seniors? None of this was discussed or addressed. This policy is an attempt to define and quantify a set minimal quantity of two, 2, blood glucose strips per day are linked with orders for Dexcom 5 components. The lack of blood glucose strips as glucose is falling during exercise periods makes no sense. T1ds are better served with a sufficient number of blood glucose strip to maintain and improve our exercise programs for improved health outcomes. A hypoglycemic event(s) is far more dangerous than a hyperglycemic event(s). The hyperglycemic event can be reduced with an insulin dose. However, hypoglycemic events require a very quick response which can have an onset of less than one hour.

    1. Is safety for the life of a T1d important? There are many products available to assist seniors’ to minimize falls. How are senior T1d affected? A senior entering a rapidly dropping low blood glucose needs immediate help. We do not need to increase the danger of falling due to an inability to respond to an immediate hypoglycemic event. Seniors are further complicated by a medical fact that they do not recognize the depth and breadth of the speed that blood glucose is falling without the use of a CGM. The viewing of the treading blood glucose levels every five minutes is one of the outstanding features of a Dexcom CGM.
    2. The answer for a dangerous falling of glucose readings as a hypoglycemic event is proceeding is complex.   There are no simple answers. It requires on-going discussions and analysis as part of our personal relationship with our physician.  The ability to observe and quantify trending levels via a Dexcom 5 CGM with other individuals is a great support improvement for a T1d patient.
    3. Medicare rules are destroying the best function of a Dexcom 5. It is the ability to share glucose trends via readings every five minutes with an iPhone. Medicare has gone to the point of attempting to punish seniors with another additional vindictive restriction.
  • The May 4, 2017, Joint DME MAC Article was posted May 4, 2017. The excerpted critical language is: . . . .If a beneficiary uses a non-DME device (smart phone, table, etc.) as the display, either separately or in combination with a receiver classified as DME, the supply allowance is non-Covered by Medicare.
  • As a senior with an iPhone, we have the ability to view the Dexcom 5 CGM trending glucose levels of adult children and grandchildren. By effectively blocking this sharing tool to a Medicare senior blocks the ability of adult children to monitor their parents. The Dexcom 5 has proved to be a major safety factor for T1d children during times away from their parents. The point can be made that the senior population needs the same tools to avoid hypoglycemic event(s) with the assistance of others via the sharing of CGM blood glucose trends.
  • Where are the back-up safety consideration for a senior diabetic? Medicare has demonstrated a tendency to raise warranty period above the approved FDA notifications. What are the options should an insulin pump and/or the Dexcom 5 CGM go down or become non-functional? Being able to return to a short-term comprehensive blood glucose management program can be a life-saving backup to mechanical stoppages and failures. This again supports the need for continual blood glucose strips. Why is Medicare stepping again into the doctor-patient relationship to demand the control of the number of blood glucose strips?
  • Blood glucose strips still are needed to deal with the ever present threat of hypoglycemic event(s). The threat of hyperglycemic events can be corrected by therapeutic individual insulin dosing. However, it does not mitigate or prevent the ever present challenge of avoiding multiple, quickly approaching, and severe hypoglycemic events during a daily routine by a population which has lost the ability to recognize such a deadly threat. Medicare should be stopped, blocked and prevented from initiating policies which place diabetic seniors in such dangerous, disastrous and possible deadly situations. Medicare is failing the diabetic community and this needs to be fixed by the President and Congress. Medicare is too opaque and too slow to initiate positive changes. Medicare seniors are in need of a patient centered healthcare approach by this federal agency. Medicare should never be my personal diabetic endocrinologist!
  • Respectfully submitted. 

 

 

 

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MEDICARE SENIORS WITH DIABETES NEED A FAIRY GODMOTHER

Have you had the opportunity to hear, read or view the fairy tale of Cinderella? Watching children in a group, listening to the reader of such a tale can bring insights to all of us. Adults included.

In story-land there is a condition set down by the Fairy Godmother of Cinderella. For Cinderella it was to be home by midnight! If not, everything would revert to its original status after midnight. There was one specific condition for Cinderella.

Congress is debating new healthcare proposal options for the private sector. The President desires that the Veterans Administration initiate changes to improve coverage for members who have served our country. It is my position that there is another, a very large population, which has not been entered into the discussion of the health and the healthcare of America. It is the senior population under Medicare.

I turned 65 years young in May 1964. My healthcare was transitioned from a non-Medicare plan to a Medicare Advantage Plan. It has proved to be an antiquated rules based system. Change is only brought forward by a new or revised rule. It would be a good question to ask how I came to this conclusion.

Almost, all Americans including Medicare Advantage Plans are required to make a choice of plans and coverage during a period from October – December, and for this set of examples in calendar year 2016. Now, just what the #$*!?% is going on.   Starting in January 1, 2017, the flood of changes began.

Yes, I received a healthcare card. Oh, it had the name of a different primary physician when compared to 2016. My 2016 physician is now considered to be an out-of-service physician in 2017. Most physicians are linked with a local hospital(s). What is the status of the local hospital? Is the doctor and hospital In-network or Out-of-network? Should you need emergency services, this becomes an important question should one need to stay at the hospital. Oh, be sure to check on the emergency room physicians’ assignment if you are checked into the hospital. The wrong coding can lead to a sizeable personal bill. Coding is critical for your hospital stay. Who made the decision? How did the hospital staff consult with the patient and were they able to have a lucid conversation with the patient? This is another question that will potentially impact one’s personal financial obligations related to coverage. Now, what about the back room questions.

Should one ever attempt to visit the local pharmacy between January 2-5 you will view lines due to two different facts. Did the prescription(s) from 2016 carry forward into 2017 and where is your new healthcare card?

Oh, the healthcare changed my doctor and I need a new prescription. A new physician, new forms, a new appointment in a timely manner while I am running out of medication. The pharmacy needs a copy of our new healthcare card for coverage information. It is interesting to note that holiday bills from 2016 come due in January of 2017, at the same time that healthcare deductibles start!

As a type 1 diabetic, there are supplies which may be covered as a durable medical equipment, DME, and can include equipment components such as blood glucose meters and pumps.  Maybe??!

Oh, guess what, the medical supply organization from the prior year 2016 is no longer an In-service provider for specific durable medical equipment (DME) under my 2017 Medicare Advantage Plan. Finding out in late February 2017 that a component from a prior year’s approved supplier, with an extended prescription/order,  with the necessary information from the physician are not covered means the senior is on the hook for the cost of certain DME components.  Your blood glucose meter and your insulin pump are defined as a DME. How did Medicate get out of covering what used to be considered as DME appropriate components? They have an annual bidding process with a focus on the cheapest price. Do you always buy the cheapest without any consideration for quality and need?  There is only one winner chosen!  How did three different fast acting insulins with separate Food and Drug Administration approvals become identical.  Chemically they are different and they each have their own characteristics. With three fast acting insulins for a pump, only one will be covered as a DME supply item. Welcome to the deductible pharmacy item category and donut-hole issues.  If the insulin for your pump was not the single winner you lose. How do you feel about being told, directed, etc., to change the insulin in your pump?   Oh, Medicare changed the warranty period established by the Food and Drug Administration from four years to five years before one is able to upgrade your current model pump. Are you ready to re-calibrate your insulin pump for new insulin to carb ratios, insulin sensitivity, and etc. with only four endocrinologist appointments for the year? What happens if the fast acting insulin is changed  again in 2018 to a different brand? Have you ever seen an Annual Formulary List?

The prior approved and now a non-covered vendor needs to be paid, the patient is in need of DME component supplies and the only option for the patient is to start a Medicare appeal. Really! I have filed an appeal for a January order for Dexcom sensors for my Dexcom G4.   The February order of sensors, again denied and was forced to file a new appeal again.  Oh, add finding a new medical supplier, who is an In-service provider and having the physician’s office re-send another set of clinical documents to another medical supplier of DME components.  Oh, add in a request to upgrade my Dexcom G 4 CGM to a Dexcom G 5 on March 27, 2017.  It was summarily denied, due to the use of the old billing codes.  Billing codes!  That is really an interesting position for a denial.  Currently, there are three appeals with my healthcare provider.  In March of 2017, my G 4 sensors needed to be replaced and I needed a new transmitter.   I am currently running on empty concerning my Dexcom G 4 CGM components with no consideration from the healthcare provider.  My Dexcom G 4 CGM has been covered from the beginning of my Medicare enrollment through December 2016 due to favorable ruling in a Medicare Appeal process. This is the link to the successful appeal:   http://www.ajmc.com/journals/evidence-based-diabetes-management/2016/may-2016/a-medicare-appeal-for-cgm-coverage-one-patients-never-ending-story

The last hassle is the lack to medical support by Medicare. Medicare has been fighting the introduction of a personal continuous glucose monitoring system, pCGM, for at least five years since 2012. Have any of you ever viewed the clinical reports and references which Medicare uses to make their decisions?

Medicare issued a new CMS Ruling on January 12, 2017, with approval of just the Dexcom G 5 CGM. Medicare has started to lay down a new set of revised restrictions. The most onerous is to deny the use of the ability of an approved Dexcom G 5 for a Medicare senior. What is the issue?  It is interesting to note that a type 1 child as young as five years and individuals through the age of 64 plus years can be approved in two steps for a Dexcom G 5.   What is the point of restricting the communication ability of the Dexcom G 5 information to other family members for seniors and approving this communication link to the parents of young children? Are you telling me that adult children of type 1 diabetic parents do not need any help with parents living with diabetes?

Medicare by their actions regarding the approval of the “therapeutic Dexcom G 5 demonstrate that Medicare does not have the ability to initiate the introduction of new medical technology for the senior population of American. The Food and Drug Administration has a better transparency concerning their approval process. What is the approval process for Medicare? They are proving to be very opaque with their processes. Why were the Medicare Advisory Contractors, MAC, responsible for writing the operational rules for billing and processing requests for Medicare Advantage Plan seniors?  Will these new set of rules be extended by healthcare providers to non-Medicare plans?

Going through a Medicare Appeal Process for Part A and Part B is another process that needs to be changed. An individual started a Medicare Appeal process for coverage of a Dexcom G 4 unit. The process was started in early 2012 and was not settled until late 2016. This particular case when through the entire five appeal steps and seven separate hearings. Now here is the real kicker. When one proceeds through a Medicare Appeal process and is successful, how long is that particular ruling effective?

Reading the approval process steps for a Dexcom G 5 CGM in a Medicare Contractor notification dated March 23, 2017 does not demonstrate a very open process for the seniors of American. There are too many conditions and it takes too long. Seniors with Diabetes need Congress and the President to step forward to reduce and minimize the arcane, opaque, and untimely rules which have grown over the years in the delivery of complex Medicare rulings and decisions in the name of the federal government.   This is a disservice to the seniors of American.

Cinderella had a person willing to find her. The only criterion involved the ability to be able to wear the glass slipper. All type 1 diabetics wear a glass slipper, our diabetes.  Diabetes is a very delicate matter to control. We need your help!   We do not all wear the SAME glass shoe size.  There is no sense in trying to wear each others’ glass shoe.  We all need our own unique shoe.

Respectfully submitted

SHOULD CGM STANDARDS BE APPLIED EQUALLY?

 

At the beginning of this year, the Centers for Medicare & Medicaid Services issued a new ruling, CMS-1682-R, dated January 12, 2017. This ruling has now defined a classification of: Therapeutic Continuous Glucose Monitors as “Durable Medical Equipment”. At this moment, the Dexcom G 5 continuous glucose monitor is the only therapeutic continuous glucose monitor. At the end of March 2017, my Dexcom G 4 has sensors and a transmitter out of warranty. My position is simple. I requested a Dexcom G 5 CGM. It was summarily denied. Why? The medical supplier utilized the standard billing codes for CGM components and Medicare deems the entire request as non-covered because of the billing codes. Really! What happened to a review of medical criteria for the service?

It is my position that Medicare has boxed itself into a corner. The time has come for Medicare to apply medical standards equally when compared to the non-Medicare population. Why should seniors have different medical criteria and codings when compared to our children and adult children when all are type 1 diabetics?

The starting point is the current Local Coverage Article: Glucose Monitor – Policy Article (A52464). The onerous line is on page 3 of 7.

“Continuous GLUCOSE MONITORs (A9276-A9278) is non-covered

Under the DME benefit.”

Also note on the beginning pages of Article (A52464) is the list of Contractor Information.   The list defines regions of the country to specific contractors. One way to look at the contractors is that they serve as enforcers for Medicare delivery. Should Medicare Local Coverage Articles be promulgated by the contractors? How does Medicare and the Contractors determine their decisions? Are any of you aware of this group publishing the results of any clinical studies or reference any studies?   Who is responsible for their decisions and what, if any is the process to request a reconsideration on the Local Coverage Articles? Why is the Medicare Appeal Process only an individual case-by-case determination?

The Department of Health and Human Services, Centers for Medicare & Medicaid Service issued a CMS Ruling. Ruling No.; [CMS-1682-R] dated January 12, 2017. For the Medicare Program, Medicare Supplement Medical Insurance (Part B) declared Classification of Therapeutic Continuous Glucose Monitors as “Durable Medical Equipment” under Medicare Part B.

The ruling was written with no consideration for implementation. What is covered, when is it covered, how is it covered and who is covered? The operative factor not addressed is the length of time needed to fully implement this ruling.

Medicare contractors have issued another article on March 23, 2017. An excellent review was written by Mary Caffrey for the American Journal of Managed Care, on March 28, 2017. This online review critics the restrictions that are destroying a coverage choice for Dexcom G 5 units via Medicare. There is another interesting Medicare document that can be brought into the picture for clarity concerning the implementation for the use of approved Dexcom G 5 CGMs Medicare does have a document which lists Durable medical equipment (DME) coverage.

It is obvious to me that there is no plan for implementation!   Is it the ultimate goal of Medicare to enforce policies to remove and destroy the historically important doctor-patient relationships?

 

Recommendation for implementation from a Medicare senior and a type 1 diabetic for over fifty years.

    1. There is no reason to change the billing codes of (A9276-A9278) for the sensors, transmitters and receivers of a CGM. Dexcom included.  The above referenced billing codes are applicable to children through adults through age 64 plus.
    2. There are multiple levels of contractual agreements between many parties involving coding coverage to aid in reimbursement for various parties. Why should private insurance organizations, medical supple companies, hospitals, pharmacies, and billing organization have different number codes for the same pieces of equipment? And be required to change them mid-year. There is a serious cost to implement a revised coding adjustment and could include training. Does anyone have any idea the time it takes to re-code billing documents for failure during a transition period mid-year without clear directions?
    3. Interesting facts: My first Dexcom unit was approved when I was 63 years young in December 2012-Janmuary 2013. The discussion was first between myself and my endocrinologist, prescription/orders were forwarded to a medical supply house which forwarded the request to my health care provider and was approved. If there was a question, it would have been a discussion between my endocrinologist and equal medical peers at the insurance company. It was approved. Who are the medical peers for Medicare and when, where and how do they enter the process? The uniform billing codes were employed. As required, my registration for Medicare was completed. Local coverage article (A472387) was in effect at the time. It took fourteen months and three levels of a CMS Appeals process for a successful approval and coverage of my Dexcom G 4 Platinum CGM.
      1. With a successful Medicare Appeal, my Medicare Advantage Plan was billed by a Medical supplier with the same codes, (A9276-A9278) as children and non-covered medicare adults. Conclusion: use the same billing codes for everyone.
      2. There is no reason to have a unique billing code just for Dexcom. What happens when future vendors and/or a newer improved therapeutic glucose monitor enters the market. Newer billing codes again!
      3. The Medicare ruling and the Local Coverage Articles are silent on integrated medical equipment. There are blood glucose monitors coordinated with an insulin pump. Next, there are insulin pumps which are coordinated with a Dexcom G 4 CGM. What is the decision for these groups of CGM users?
      4. Blood sugar monitors and blood sugar test strips are supplies defined as covered durable medical equipment (DME). Proposed rule change: add CGM sensors with billing code (A9276) as a supply item for blood sugar monitors. The CGM sensors are a type of sugar (glucose) sensor.
      5. Second Proposed rule change add the CGM transmitter, (A9277) and the CGM receiver, (A9278) as a supply item for insulin pumps.  Conclusion: Is it the desire of Medicare to pay for the transition from insulin pumps with Dexcom G 4s to new pumps and Dexcom G 5 CGM units NOW, or wait until they become available. Recommendation: Cover the Dexcom G 4 components linked to an insulin pump and/or blood glucose meters with the opportunity to transition as quickly as possible. Such an action could stabilize the markets and present an option for new entries into Medicare.
      6. The successful transition to full utilization could take four years. This is based upon the fact that Medicare has ongoing new enrollees. Why should new enrollees have important diabetic medical equipment taken away? Especially, when approval had been granted prior to the new enrollee becoming Medicare eligible. The four year window is linked to the warranty period of prior approved pumps and other diabetic management equipment.
      7. Serious consideration needs to be given to drastically change the current Medical appeal process for Part A and B. How would you feel if a Medicare appeal which was started in 2012, and was not settled until December 2016 with a total of seven different hearings? This specific appeal was for approval of coverage for a Dexcom G 4 CGM.
      8. Will this person and all other prior successful recipients of approved Medicare coverage for Dexcom G 4 CGMs have the option to transition to the newly approved therapeutic Dexcom G 5? If not.   Why not?  They had previous been approved with coverage for all CGM components
      9. Final recommendation: Medicare should simply revise Local Coverage Article (A52464) to maximize coverage and minimize disruptions for a better transition approach to implement CMS-1682-R. This should also include a revision of the Durable medical Equipment (DME) coverage. I find it interesting to note that this document DOES NOT identify vendors directly. The earlier recommendations to the DME linkage will identify the diabetic equipment being employed by the patient and fulfill the positions established under CMS-1682-R.

In conclusion, it my concern and desire that medical standards are applied equally. There is no medical reason for Medicare to apply rules that make no sense medically given the fact that they exist in the non-medicare population. There is no logical reason or sense for the same medical insurance provider to approve a child with a Dexcom G 5 with smartphone technology for the necessary family members and then turn around and deny such coverage to Medicare seniors and their adult children. Why?

A society and culture can be judged by our concern and respect for the young and the old. It is time for Medicare to become responsive to Medicare patients. It is a waste of time, energy to tie up the delivery of medical services to arcane rules that can only be challenged though an arduous arcane appeals process which takes way to long. All non-Medicare type 1 diabetics need to be concerned. When coverage begins to slip for one part of the diabetic community the day will come when such rules will impact you and your diabetic care.

Respectfully submitted

WILL MEDICARE CGM USERS BE RIPPED OFF?

Have you ever experienced being short-sheeted in a group environment? Some may consider such an action to be funny.   When it is you, it can be a personal embarrassment. The diabetic community needs to watch very carefully to avoid the Medicare population from being ripped off by a poorly written policy by the Centers for Medicaid and Medicare Services (CMS).

CMS has begun to draft a policy regarding personal continuous glucose monitoring units (pCGM). The diaTribe website has published an article dated January 13, 2017, concerning the announcement by CMS on the Critical First Step Toward Medicare Coverage of CGM. The diabetic community needs to stay on guard so that the development of the new policy does not rip us off.

It is interesting to note that Medicare has a habit of changing the warranty period as defined in the FDA rulings and within the same CMS-1682-R ruling! Page 6, of this CMS ruling states: “Once the coating wears off in 6 or 7 days, the sensor must be replaced for safety reasons”. Later, on page 13, of this CMS ruling states: “The monthly fee schedule amount is established using invoice prices for four sensors”. 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. Four sensors per month would be equal to 48 sensors per year. A year has twelve months. A non-leap year has 365 days per year and a leap year has 366. What would be the value when 365 days is divided by a 7 day sensor period? The answer is 52.14. We cannot purchase a pro-rata portion of a sensor. We need to round up to a whole number. Result for a 365 day year would be equal to 53 sensors per year! The difference between 53 sensors and 48 sensors is a total of five sensors. They are not equal to each other. How do you feel about being five sensors short per year? Could this be called a rip-off?

I am thankful for the article which the team from the diaTribe website for their dedication on this very important and necessary need for the diabetic community. We need to stay on guard. The detail is critical. For CMS, write a common sense and easily readable policy from the start. Take the time to study the facts and stay consistent with the warranty periods and the language. For my non-Medicare diabetic friends, this is important to you. The finalization of a sloppy policy can result in serious, dangerous, and dilatory consequence for all physicians, medical personal and diabetic patients. Being ripped off of the number of sensors needed per year could place the life of seniors at risk

WHO ARE THE PLAYERS IN DRUG PRICING?

 

As a type 1 diabetic, (T1D), I find the maze of price and restrictive rules which are raising the price of insulin are insidious. Denise Roland and Peter Loftus wrote in a Wall Street Journal article dated October 7, 2016, entitled; “Insulin Prices Soar While Drugmakers Share Stays Flat”. If the manufacturer of insulin is not profiting from the price rise of insulin than who is?

Peter Loftus next wrote in a Wall Street article dated October 28, 2016, entitled; “Backlash against Drug Prices Hits Manufactures and Middlemen”.

DiabeteMine Team from Healthline wrote in a January 24, 2017 release, entitled; “Who Are Pharmacy Benefit Managers (PBMs) and How Do They Influence Drug Pricing”.

There is still one organization that is a player and their impact has yet to be discussed. What is the role of the Centers for Medicaid and Medicare, (CMS)?  The opening page of the CMS website is clear. CMS covers 100 million people.

The case can be made that there are additional procedural paths that need to be identified for further review of the recent ongoing rise in the price for insulin in the USA.

  1. Who is responsible for the preparation of an annual formulary list?
  2. Do all organizations comply with a singular annual formulary list?  If not does the ability to review and exam an organization’s formulary list prior to a sign-up period for new calendar year of health care coverage exist?
  3. There is a need to examine the progressive changed in the formulary lists for the last eight years. My suggestion is calendar years 2009 through 2017.
  4. When. Where, Why and How was the change in insulin initiated on a formulary list to only include one choice of short term insulin. In particular, Humalog, Novolog and Apidra. The appeal process for an insulin choice not on the formulary list is time consuming process as well as addition cost increases to the patient.
  5. When, where and how does the bidding process of the government, which could be another governmental organization, enter into this annual decision?

It is interesting to note that in simple terms insulin is a manufacturer product. What is the best timely inexpensive processes to deliver the manufactured product, insulin, to Type 1 diabees and other diabetic patients on an insulin program?

The management of glucose levels with insulin for diabetics entails far more than just access to insulin. It demands an ongoing monitoring of the multi-factors that impact a person living with diabetes. The change in the choice of an insulin product should be focused on the doctor-patient relationship and not defined by an ever changing bureaucratic formulary list.

 

A COMMENT REGARDING CMS RULING ON DEXCOM G5 By Dan Patrick

 

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.

WHAT ABOUT THE PATIENT NEEDS?

The only word that I find appropriate to describe the maze of price and restrictive rules raising the price of life-saving drugs is deadly. The New York Times, August 22, 2016. detailed the EpiPen Price Rise for Allergy Sufferers. Allergy sufferers require an EpiPen to respond quickly to an external attack on their bodies and need immediate medication to counter the external attack on their bodies.  As a type 1 diabetic, (T1D), I find the maze of price and restrictive rules which are raising the price of insulin is far more insidious. Denise Roland and Peter Loftus wrote in a Wall Street Journal article dated October 7, 2016, entitled; Insulin Prices Soar While Drugmakers Share Stays Flat. If the manufacturer of insulin is not profiting from the price rise of insulin than who is?

The diabetes community is taking actions to deal with this pressing issue. Mike Hoskins from DiabetesMine wrote about a stay-at-home mom from Mississippi with her attempt to crack the code on insulin profits. The American Diabetes Association, (ADA) has stepped forward and is launching a petition for affordable insulin. The petition can be signed at the ADA website. Peter Loftus wrote in a Wall Street article dated October 28, 2016, entitled; Backlash against Drug Prices Hits Manufactures and Middlemen. It is interesting to note that in simple terms insulin is a manufacturer product. What is the best timely inexpensive processes to deliver the manufactured product insulin to the T1D patients?

The management of glucose levels with insulin for diabetics entails far more than just access to insulin. It demands an ongoing monitoring of the multi-factors that impact a person living with diabetes.

The starting point is the preparation of insulin for person with a body that no longer produces insulin.

The drug companies first turned to animal refined insulin. Back in 1966, at the start of my T1D career the choices were bovine, beef or porcine, pig insulin products. These early choices were predicated on the ability to lower glucose levels and minimize personal body irritants with the given choices. In the late 1980’s an insulin pump was added to my care. It is now 2016. My history with insulin pumps and blood glucose meters has expanded. I have selectively used each of the three different fast acting analogue derivatives of insulin. Currently, the three choices of fast acting insulin are Humalog, Novolog, and Apidra. The current best choice for me in coordination with my insulin pump, blood glucose meter, continuous glucose meter and continual consultations with my endocrinologist is Apidra.

What is the current landscape regarding the patient choice of insulin?   Each year over the last four years my health care provider (HCP) has sent me notifications. The notification dictates what singular choice of fast acting insulin that I should use. Really? How was this determination made? Who made the decision?  Where is the clinical data to support the fact that T1D users should be forced to comply with an assigned choice due to cost and deductible coverage factors without discussion with the patient’s doctor? For 2017, my only Formulary choice is Novolog. The operative question is: What is the point of having T1D patients potentially have to change their use of rapid acting insulin each and every year without any medical discussion of the impact and coordination of all necessary equipment supplies, other medications and necessary medical appointments?

The starting point is the retail price for each of the three in 100 Unit/ml injection vials. In October 2016, the local pharmacy supplied to following data. If I had to purchase insulin on a retail basis and absorb the entire cost of the medication without the purchase being applied to a deductible is:

 

Humalog                              $309.99               Eli Lily Company, USA

Novolog                                   310.99                Novo Nordisk, Denmark

Apidra                                      333.99                Sanofi US

 

The question at hand is the procedural choice of a singular bidding process with the only focus being the lowest cost for insulin. Did anyone give consideration to the question of what is best for type 1 diabetic patients? T1D patients run the range in age from eleven (11) months after birth to eighty years as type 1 diabetics. Can any of you fit into your baby shoes for an entire life? There is a reason for the multiplicity of insulin type products. What is best for the patient is a critical question to ask. One singular choice is not the best answer.

Upon further examination the three fast acting insulin listed above are not identical. They are structurally different with subtle differences. Humalog is a rapid-acting human insulin analog. It is an Insulin lispro produced by recombinant DNA technology. Novolog is rapid-acting human insulin analog and is an insulin aspart. It has an rDNA origin. Apidra is a rapid-acting human insulin. It is an insulin glulisine with an rDNA origin in which is different from the other two. The short answer is the fact that all three insulins are different with different structural components. Yes, they are insulin in the general sense in that each will facilitate the ability to lower blood sugar. However, each has a different set of characteristics and warnings which can be very critical to the T1D patient. The three insulins listed are not generic drugs!  Each is unique.   They were approved by the Food and Drug Administration at different times due to the fact they are different.  How well does the choice work with an approved pump and necessary supplies? How fast will the choice bring down a meal glucose rise? What is the impact upon the onset of hypoglycemic events? A search on the internet can list various factors that can affect the ability of each to optimize the patient’s goal for a desired normal glucose. What really is the reason that Medicare and many other insurance providers have been attempting to dictate a singular insulin choice for coverage on their Formulary list of approved drugs which can be changed during the upcoming given year or the future years?

There are diabetic focused organizations along with the federal government who support research for a possible cure for diabetes. The search for a cure has led to and will continue to lead to advances which have improved and will continue to improve the management of our diabetic condition. The dichotomy of dollars for research being offset by the petty denial of the use of new tools is both stupid and dangerous to diabetic patients’ lives. Let’s take the time to file any and all appeals for coverage and work to change a broken system. As a diabetic patient it is my desire for the opportunity to live the best possible life as a diabetic patient!  It is my belief that this is your desire as well.

 

An A1C EXAM Part 2A

 

Similar to many of other diabetics, I have ongoing laboratory A1c blood tests prior to each scheduled Endo appointments. Could Dexcom Clarity software reporting present a key to compare my laboratory results as a tool for daily choices?

For many diabetics, both type1 (T1D) and type2, routinely have hemoglobin A1c (A1C) tests as part of their medical appointments. The thoughts and feelings of many T1D run the gambit. Feelings of fear, disgust, failure, shame and disappointment are only just a few due to the fact that A1C results are used to assess diabetes therapy. Have you ever chosen to not study and took an exam without any preparation for a final exam grade?  For many of us, this author included, exams can be a very challenging event. This raises the question. How can a T1D prepare for an A1C exam? What do we measure, when do we measure, how do we measure are all key questions?

Peter Drucker once said, “If you can’t measure it, you can’t improve it.” Let us look at changing the question facing a T1D. How can we take immediate actions during each and every day that could result in improved A1C results?

In January 2013, I launched the start of collecting and analyzing my continuous glucose readings with the start of a Personal Dexcom G4 Platinum continuous glucose monitor (PCGM). A YouTube, 3DviaT1D is a presentation of my startup and desires with the addition of a Dexcom unit. The next, challenge came with my 65th birthday. The fight with Medicare was over the best approach to manage my condition with my use of a PCGM unit

Using selected reports from Dexcom Studio software, reports were assembled to support the importance and value of using a PCGM. An article has appeared in the American Journal of Managed Care regarding my Medicare Appeal fight. Be sure to reference the pdf link to the complete article which contains five figures. After a twenty-four month period, the figures demonstrated that hypo and hyperglycemic events had been reduced. The objective of near normal blood glucose via A1C of 7.0% without the two to three fold increase in hypoglycemic events which was a major factor reported in the Diabetes Control and Complication Study.

Now, what can we assemble in ongoing reports from the new Dexcom Clarity software? The period reporting results which were chosen. They can be found in Table A. DEXCOM G4 Pt via DEXCOM Clarity Reporting.

A.   DEXCOM G4 Pt via DEXCOM Clarity Reporting
Average CGM
Date CGM Standard
Start End Range Estimated glucose Deviation
Date Date in days A1C mg/dL mg/dL
6/23/16 7/7/16 15 6.9% 152 61
7/8/16 7/22/16 15 6.4% 137 49
7/23/16 8/6/16 15 6.5% 139 46
8/7/16 8/21/16 15 6.6% 142 46
8/22/16 9/5/16 15 6.7% 147 51
9/6/16 9/20/16 15 6.6% 144 50
06/23/16 07/22/16 30 6.7% 145 56
07/23/16 08/21/16 30 6.5% 141 46
08/22/16 09/20/16 30 6.7% 145 51
06/23/16 08/06/16 45 6.6% 143 53
08/07/16 09/20/16 45 6.7% 144 49
06/23/16 07/22/16 30 6.7% 145 56
07/23/16 09/20/16 60 6.6% 143 48
06/23/16 09/20/16 90 6.6% 144 51
B.   Laboratory Results
Actual Glucose
Date   A1C mg/dL
9/20/16 blank 6.9% 151
C.   Comparative Results
9/6/16 9/20/16 15 6.6% 144 50
08/22/16 09/20/16 30 6.7% 145 51
08/07/16 09/20/16 45 6.7% 144 49
07/23/16 09/20/16 60 6.6% 143 48
06/23/16 09/20/16 90 6.6% 144 51
D. Comparative Accuracy Dexcom Est to Lab Actual A1c
% Ratio
Days Prior Est A1c to
to 9/20/16 Lab A1c
15 95.7%
30 97.1%
45 97.1%
60 95.7%
90 95.7%

 

There have been various comments regarding the accuracy and the time frame windows for A1C exam readings given the fact that an A1C reading is just one number as an average of blood glucose attached to a hemoglobin molecule. It is interesting to note that the data presented above for estimated A1C has a high correlation to the precise value obtained by the laboratory for A1C and Glucose level over various iterations of time frames.

How were the Dexcom Clarity Reports Assembled?

    1. The determined data range was adjusted and changed in the Overview Designation below your name.
    2. Next the report was produced and run from the Data Designation below your name.
  • Finally, a report was produced and run from the Compare Designation below your name.

 

  1. It was after receiving my A1C results from the laboratory, September 20, 2016, that the various time range reports were run and assembled into the matrix table listed above.

The ability does exist through the use of Dexcom Clarity to get a feel as to the range of one’s estimated A1C via their Dexcom reports prior to your A1C test. Table C, Comparative Results, listed above demonstrates a high correlation to the actual laboratory results. Anyone using a Dexcom unit, either G4 or G5 has the ability to view moving glucose levels. It is the small day to day adjustments which can bring about a change in results. How can we take actions to change the direction of the glucose flow direction as reported on our receiver unit or cell phone? One suggestion is to get a copy of Sugar Surfing by Dr. Stephen Ponder. Dr. Ponder is a pediatric endocrinologist and certified diabetes educator.

Table D, Comparative Accuracy Dexcom Est to Lab Actual A1c shows a high degree of accuracy of the Dexcom Est A1c to the Actual Laboratory A1c.

You may ask what can be done to improve the accuracy of your Clarity reports compared to your laboratory A1c results? Dexcom has prepared a “User’s Guide. Section 7.2 is How to Calibrate”. There are five bullet points, one Warning and one Precaution. There is another fact that we need to take into consideration. What is the accuracy of you particular blood glucose strips? This can be critical given the fact that we utilize a blood glucose reading every 12 hours. Using the extremes from Table D, an actual blood glucose meter reading of 100 mg/dL with a 10% accuracy factor computes to a range of 90 mg/dL to 110 mg/dL. A   blood glucose meter reading of 400 mg/dL with a 25% accuracy factor computes to a range of 300 mg/dL to 500 mg/dL.

Compare Actual Blood Glucose Reading to
the Range of Blood Glucose Reading adjusted for
A B C D
Actual Range
Glucose Accuracy Low High
mg/dL Factor A – (A)x(B) A + (A)x(B)
100 10.0% 90 110
100 15.0% 85 115
100 20.0% 80 120
100 25.0% 75 125
200 10.0% 180 220
200 15.0% 170 230
200 20.0% 160 240
200 25.0% 150 250
300 10.0% 270 330
300 15.0% 255 345
300 20.0% 240 360
300 25.0% 225 375
400 10.0% 360 440
400 15.0% 340 460
400 20.0% 320 480
400 25.0% 300 500

 

As diabetics we need to take action with mechanical devises and directed actions to drive our glucose levels to a near normal ranges and reduce the roller coaster events for each and every day. You can check your daily results. Again, in Dexcom Clarity go to the Data Designation. Below your name and time frame title, on the far left are three choices. Click Daily. Now you have supporting documentation as to what is happening on a daily basis. Documented output facilitates discussions with health care professionals to determine optimal approaches.   It is the ongoing success of small changes repeated over time that can have the potential for better A1C exam results. Best of success in taking actions to prepare for your next A1C examination.

An A1C EXAM

 

Recently the Food and Drug Administration (FDA) hosted a Public Workshop on August 29, 2016. An excellent article was written in advance of the Workshop by the diaTribe members. The focus of the FDA meeting was “Going Beyond A1c – One Outcome Can’t Do It All”.

For many diabetics, both type1 (T1D) and type2, routinely have hemoglobin A1c (A1C) tests as part of their medical appointments. The thoughts and feelings of many T1D run the gambit. Feelings of fear, disgust, failure, shame and disappointment are only just a few due to the fact that A1C results are used to assess diabetes therapy. Have you ever chosen to not study and took an exam without any preparation for a final exam grade?  For many of us, this author included, exams can be a very challenging event. This raises the question. How can a T1D prepare for an A1C exam? What do we measure, when do we measure, how do we measure are all key questions?

Peter Drucker once said, “If you can’t measure it, you can’t improve it.” Let us look at changing the question facing a T1D. How can we take immediate actions during each and every day that could result in improved A1C results?

In January 2013, I launched the start of collecting and analyzing my continuous glucose readings with the start of a Personal Dexcom G4 Platinum continuous glucose monitor (PCGM). A YouTube, 3DviaT1D is a presentation of my startup and desires with the addition of a Dexcom unit. The next, challenge came with my 65th birthday. The fight with Medicare was over the best approach to manage my condition with my use of a PCGM unit

Using selected reports from Dexcom Studio software, reports were assembled to support the importance and value of using a PCGM. An article has appeared in the American Journal of Managed Care regarding my Medicare Appeal fight. Be sure to reference the pdf link to the complete article which contains five figures. After a twenty-four month period, the figures demonstrated that hypo and hyperglycemic events had been reduced. The objective of near normal blood glucose via A1C of 7.0% without the two to three fold increase in hypoglycemic events which was a major factor reported in the Diabetes Control and Complication Study.

Now, what can we assemble in ongoing reports which can assist T1Ds in gaining better control in our A1C tests? The FDA August 29, 2016 meeting date was one month prior to my next endocrinologist appointment in September 2016. My A1C exam was taken on September 20, 2016. Could Dexcom Clarity software reporting present a key to compare my laboratory results and a tool for daily choices? The period reporting results were as follows:

A.   DEXCOM Readings from DEXCOM Clarity Reports
Average CGM
Date CGM Standard
Start End Range Estimated glucose Deviation
Date Date in days A1C mg/dL mg/dL
08/22/16 09/05/16 15 6.7% 147 51
09/06/16 09/20/16 15 6.6% 144 50
06/23/16 07/22/16 30 6.7% 145 56
07/23/16 08/21/16 30 6.5% 141 46
08/22/16 09/20/16 30 6.7% 145 51
06/23/16 08/06/16 45 6.6% 143 53
08/07/16 09/20/16 45 6.7% 144 49
06/23/16 09/20/16 90 6.6% 144 51
B.   Laboratory Results
Actual Glucose
Date   A1C mg/dL
9/20/2016 . . . . . . . . . 6.9% 151

 

There have been various comments regarding the accuracy and the time frame windows for A1C exam readings given the fact that an A1C reading is just one number as an average of blood glucose attached to a hemoglobin molecule. It is interesting to note that the data presented above for estimated A1C has a high correlation to the precise value obtained by the laboratory for A1C and Glucose level over various iterations of time frames.

How were the Dexcom Clarity Reports Assembled?

    1. The determined data range was adjusted and changed in the Overview Designation below your name.
    2. Next the report was produced and run from the Data Designation below your name.
    3. Finally, a report was produced and run from the Compare Designation below your name.
    4. It was after receiving my A1C results from the laboratory, September 20, 2016, that the various time range reports were run and assembled into the matrix table listed above.

 

The ability does exist through the use of Dexcom Clarity to get a feel as to the range of one’s estimated A1C via their Dexcom reports prior to your A1C test. The comparison listed above demonstrates a high correlation to the actual laboratory results. Anyone using a Dexcom unit, either G4 or G5 has the ability to view moving glucose levels. It is the small day to day adjustments which can bring about a change in results. How can we take actions to change the direction of the glucose flow direction as reported on our receiver unit or cell phone? One suggestion is to get a copy of Sugar Surfing by Dr. Stephen Ponder. Dr. Ponder is a pediatric endocrinologist and certified diabetes educator.

As diabetics we need to take action with mechanical devises and directed actions to drive our glucose levels to a near normal ranges and reduce the roller coaster events for each and every day. You can check your daily results. Again, in Dexcom Clarity go to the Data Designation. Below your name and time frame title, on the far left are three choices. Click Daily. Now you have supporting documentation as to what is happening on a daily basis. Documented output facilitates discussions with health care professionals to determine optimal approaches. It is the ongoing success of small changes repeated over time that can have the potential for better A1C exam results.

WHO IS YOUR EXERCISE BUDDY?

As a type one diabetic, T1D, I realize and am aware of the fact that the big three are insulin, food, and exercise. In an earlier post, “Appreciation for a Heroine”, I wrote about our family dog, Maggie, and how she was my sleep period continuous glucose monitor. Based upon her ten year outstanding performance, I did not have any runs to the hospital with hypoglycemic events. She served as my exercise buddy for over thirteen plus years! We would have multiple walks each and every day. The practical reason was that the family did not want to clean up messes in the house. When we were forced to put Maggie down, I lost a true Exercise Buddy. Now, my search for a continuous glucose monitor was placed into high gear. The loss of a family dog is a major event which hit the entire family. So, my daughter when into action and decided that we needed another dog. A recused Maltese entered our family.

The look can be very direct:  It is time for my walk and business!

Our new family member was named Buddy! Dad, again had the assignments of walking Buddy. He quickly became my new Exercise Buddy. Oh, I still take care of any and all messes!

Dogs hold a very special place in my heart. They know when you are feeling low. They take the time to spend very close time with us. One of their greatest gifts is their ability to stay in the moment. Whenever, I arrived home there are four furry paws just waiting to greet me with an excited smile. Yesterday is history. We cannot “fix the past”. The present can be described as a gift for the moment. It is our opportunity to use it wisely. The future is a mystery. Our exercise walks are never boring. One never knows what we will come across, where paths will take us and who will we meet and greet from morning to night.

The next change to my personal challenges with my T1D was the decision to add a Fitbit to document my (exercise) movements. My choice was a ChargeHR. A new endocrinologist became part of my new team.  What could be done to minimize the need to print out multiple pages of data? I initiated uploading my diabetic equipment into Diasend. It is the program of choice for the clinic I attend. My data was forwarded to the clinic through Diasend. This included my blood glucose meter, the insulin pump, the Dexcom G4 Platinum Continuous Glucose Meter, CGM, and my Fitbit. Now, all my equipment data is available for review prior to scheduled appointments. Insulin, food and exercise are all summarized on one sheet of paper. The Diasend reports include detailed reporting for the blood glucose meter, the insulin pump and my CGM.

The measurement of exercise is the last major area that is the real challenge for a T1D. What to collect, when to collect, how to collect, and the time of the day are only the start. The New York Times, on July 1, 2015, had an article entitled; “Older Athletes Have a Strikingly Young Fitness Age”.   Contained within the article is a method to determine our Individual Fitness Age. Feel free to check your Fitness Age.

Here is another timely article.

“Time Magazine published a Wellness article on The New Science of Exercise” The point is that doctors, researchers, scientists – even ancient philosophers – have longclaimed exercise works like a miracle drug. Now, they have proof. By Mandy Oaklander.”

The importance of exercise for a diabetes can be best described as a previously undisclosed and hidden key component to better health. The walking of the family dogs has added to my health and happiness. It is the pursuit of happiness. Exercise is not a dirty swear word. Just do it with your personal Exercise Buddy!!