Diabetics Win: CMS Rethinks Status of CGMs

photo by Carol Duff

Health Editor’s Note:  Some background for those who do not have diabetes and do need not monitor their blood glucose, which is the daily (often more than once per day) checking to see if your diet, insulin, oral insulin, exercise, weight loss routine, etc. is keeping your blood glucose levels within the “healthy for your body” range.

Checking the amount of sugar (glucose) in your blood can be done with placing a drop of your blood into a little device that will give you a number which demonstrates how much sugar is in your blood.  Or you may use a continuous glucose monitor which measures the amount of glucose inside the body. Each different CGM device collects the glucose level information in different ways while using tiny sensors. Sometimes the sensor is placed under the skin of the abdomen or can be attached to the back of the arm. You wear a transmitter on a sensor that send the information to a wireless pager monitor.

Your body cells need sugar to function properly. Using insulin, sugar (glucose) enters the cell and keeps the cell optimally functioning.  Your body is supposed to make insulin and when your blood sugar levels has normally gone up, after eating a meal, more insulin will be released which will bring the level of blood glucose back health levels. The increased amounts of insulin allows that glucose into the cells where it belongs and is used in cell functions. If you have Type 1 diabetes, where your body no longer or ever did make insulin, you will need an insulin supplement to enable the glucose to enter the cells. Think of insulin as the key to unlock the cell so glucose can move inside.  With Type 1 diabetes, your body as thrown away the key (insulin).  With Type 2 diabetes, your body still makes insulin but your cells act like the locks have been changed and will not easily allow the normal entry of glucose into the cells. For this type of diabetes you may need insulin injections, maybe along with oral insulin, closely watching your diet to limit carbohydrates, increase your exercise level, and to loose weight. Chronically high blood glucose levels, over a period of time, will lead to damage to the eyes, kidneys, blood vessels, tissues, etc.  Keeping blood glucose at normal levels will decrease the chances of blood circulation issues that can lead to tissue death and the amputation of that dead body part (toes, feet, fingers).

Regularly maintaining blood glucose at normal levels is the key to not letting diabetes harm your body.  Monitoring of blood glucose levels is paramount to staying on top of you diabetes. The ability to monitor glucose levels continuously makes this far easier. In my medical opinion, the ability to constantly monitor blood glucose levels, rather than only at meal times, bed time, upon arising, would give a clearer picture of how the body is using the insulin that is being supplemented and how the body is responding to increases in exercise, diet change, illness, etc.  These monitors have the ability to produce readings that can be sent to physician’s offices and shared.

In January of 2017 Medicare approved coverage for Dexcom G5 CGM and later Abbott’s FreeStyle Libre CGM but these CGMs were not to be used with the smartphone app that would transmit their blood glucose data.  (This seems strange to me since sending date by phone seemed like an efficient way to quickly get or send a report.)

Now Medicare has approved the use of the CGMs with smartphone apps, finally. Now they will cover the cost for the patient.  I really have to wonder who makes the decisions within Medicare, as to what they will or will not cover and why. Centers for Medicare & Medicaid Services (CMS) defines the hoops that patients and their physicians must jump through in order to make sure services are paid for by Medicare and do not become an extra expense burden for the patient.  Non-coverage of tests, etc. will limit whether the doctor will order said test. More intelligent medical decisions, made from the start, would be an improvement in this process, if the CMS continues to make the important medical decisions for America. Stop looking at the cost and concentrate on efficacy…Carol

Medicare Loosens Rules on Continuous Glucose Monitors

Will now allow beneficiaries to transmit data via smartphones

by Joyce Frieden, News Editor, MedPage Today

WASHINGTON — Clinicians will now have an easier time finding out how some of their Medicare patients with diabetes are doing, thanks to a change in Medicare’s coverage policy for continuous glucose monitors (CGMs) that use smartphone apps to transmit data.

In January 2017, the Centers for Medicare & Medicaid Services (CMS) announced that certain continuous glucose monitors would be covered by Medicare. In its announcement, the agency noted that “Medicare does not cover CGMs approved by the FDA for use as adjunctive devices to complement, not replace, information obtained from [fingerstick] blood glucose monitors. In our view, such devices are not used for making diabetes treatment decisions, such as changing one’s diet or insulin dosage … and therefore, have not been covered under Medicare.”

However, CMS added, “the FDA recently approved expanding the indications of one CGM product to include replacement of blood glucose monitors for diabetes treatment decisions.” It was that product — the Dexcom G5 CGM — that CMS approved coverage for. (Abbott’s FreeStyle Libre CGM is now also covered.) But the coverage came with a caveat: the device would only be covered if patients didn’t use the smartphone app to transmit information about their glucose readings.

According to a March 23, 2017 article from Medicare contractor CGS explaining the new coverage policy, “Coverage of the CGM system supply allowance is limited to those therapeutic CGM systems where the beneficiary ONLY uses a [CGM data] receiver classified as DME [durable medical equipment] to display glucose data. If a beneficiary uses a non-DME device (smartphone, tablet, etc.) as the display device, either separately or in combination with a receiver classified as DME, the [CGM supplies are] non-covered by Medicare.”

“That effectively eliminated the opportunity to use a smartphone together with, or on different days than, the receiver,” explained James Scott, president and CEO of Applied Policy, a consulting firm in Alexandria, Va.

The new policy, announced last month by CMS but not yet finalized, eliminates that caveat. “CMS heard from numerous stakeholders who shared their concerns that Medicare’s CGM coverage policy limited their use of CGMs in conjunction with their smartphones, preventing them from sharing data with family members, physicians, and caregivers,” the agency said. “After a thorough review of the law and our regulations, CMS is announcing that Medicare’s published coverage policy for CGMs will be modified to support the use of CGMs in conjunction with a smartphone, including the important data-sharing function they provide for patients and their families.”

“This is good news for everybody and it’s the right thing to do,” said Scott, whose clients include Dexcom and who lobbied to get the policy changed. “Most of all, it’s a victory for people with diabetes who are now able to access the full functionality of a CGM system, particularly alerts and alarms that can share unusually high or low readings with a loved one. For example, if [people with diabetes] have a high or low blood sugar while they’re asleep, the app can alert their partner who can wake them up” in time to take action.

The change will also make it easier for patients to share the information with doctors “to the extent that doctors want that information,” he continued. “For the right patients and their doctor who wants to closely watch [their readings] for a period of time … this is a big benefit.”

“This really should have happened when they [first] announced they would cover CGMs,” said Joanne Rinker, RD, CDE, director of practice and content development at the American Association of Diabetes Educators, in Chicago. “This helps the elderly who have caretakers, so they can keep up with what’s happening throughout the day.”

It also helps clinicians because “you could have a person with diabetes call their diabetes educator and say, ‘Can you look at my CGM for the last 2 days? Everything is acting crazy,’ and we can talk it through over the phone,” she said. “It gives that opportunity to be able to help in real time.”

The change will affect Medicare claims for CGMs submitted on or after June 7, 2018, according to an update from contractor CGS. CMS said it would issue a revised policy article “in the near future.”

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  1. Diabetes diagnosis and treatment is complicated by the presence of Type 1.5 (sometimes called Type 3) diabetes, an unofficial term to describe Latent Autoimmune Diabetes in Adults (LADA). It is an autoimmune disease like Type 1. https://www.diabetes.co.uk/type15-diabetes.html. It is often misdiagnosed as Type 2, which causes problems like wrong treatment. from the website, “Around 15-20% of people diagnosed with type 2 diabetes may actually have Type 1.5 diabetes. Medications designed to reduce insulin resistance do not work, as people with type 1.5 have little or no resistance to insulin.” To find out if you have Type 1.5 rather than Type 2, you can do a blood test for glutamic acid decarboxylase, or GAD, antibodies, which will be present in Type 1.5. I have a relative who I suspect needs this test. Btw, if a person has other autoimmune issues as well as diabetes, you should suspect that their diabetes is also an autoimmune type. For example, I knew someone who had Hashimoto’s thyroiditis, pernicious anemia, diabetes, and Addison’s disease, all autoimmune. She died too young, because 2 of the diseases were undiagnosed until after her death.

  2. Johnny, Yes we do seem to have more diabetics (especially Type 2), more people with Alzheimer’s, etc. We are also on the whole living longer to develop diseases and illnesses that we would have been dead before getting…We are eating foods that have been altered so that the food will be profitable to grow. Growth hormone for anyone other than a child whose pituitary gland does not make growth hormone (otherwise he or she will be a midget), is a gamble and a stupid health move…Carol

  3. Johnny, Your body either makes insulin or it does not. There could be a genetic component passed through the generations of the Yuma and Zuni. There would be the genetic component of autoimmune diseases. The Islets of Langerhans do not or stop making insulin. It takes nothing more than that. That does not mean that an individual has weak genes, just ones that are defective. Anything that is in the genes will be passed to future generations….and if the defect does not cause fatalities, then there will be subsequent generations with the same genetic material….Carol

  4. DJ C, Geez, Vaccines do not cause diabetes. Some babies, who have never been vaccinated or before being vaccinated, are born without the ability to make insulin …The Islets of Langerhans in the pancreas either never made insulin or stopped at some time due to autoimmune reasons….diabetes is an autoimmune disease. Diabetes does not come from a bad diet…..although those who have Type 2 diabetes are often over weight, do not exercise, and eat horrible diets filled with carbohydrates. Changing a diet to little carbohydrate intake and exercising may make taking insulin, in the case of a Type 2 diabetic, unnecessary. Insulin supplement for Type 1 diabetes, the body is not making any insulin, will always need insulin supplement or a transplant of the Islets of Langerhans. There are two drawbacks for the transplantation, inadequate ways to prevent islet rejection (unless from an identical twin who in all probability would also have diabetes, and the limited supply of islets for transplantation. Carol

    • Don’t concern yourself with this idiot Carol, he also insists that nuclear weapons don’t exist, so he’s just a moron not worth your time and effort.

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