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.