Lasette Laser Blood Glucose Monitoring Device
Aetna considers the Lasette laser blood glucose monitoring device , which uses a laser instead of a lancet to perforate the skin to obtain a blood sample for glucose measurement, experimental and investigational. There is insufficient evidence in the peer- reviewed medical literature that laser skin perforation offers clinically significant advantages over standard lancets.
What Are The Qualifications For Medicare Coverage For Cgms
Under the guidelines established by Medicare, the following statements must apply to you to qualify for coverage for a CGM:
- You have an established diagnosis of diabetes.
- You are currently using a blood glucose monitor.
- Your doctor recommends that you check your blood sugar four or more times every day.
- You use insulin to control diabetes, and your regimen needs to be adjusted regularly.
- You have been seeing the doctor who will prescribe the CGM for at least 6 months.
- Your doctor has taught you how to properly use the device.
For coverage to continue, you will need to see the prescribing doctor for checkups every 6 months. In addition, you must use the receiver to display your glucose readings. You may use the smartphone app in addition to the receiver to review data or send readings to your medical provider however, you can’t only use your smartphone. This rule exists because a smartphone is not classified as durable medical equipment.
Who Qualifies For Coverage
A CGM may be covered by Medicare as long as you:
- Have diabetes
- Have a personal home blood sugar monitor and check your blood sugar four or more times per day
- Take insulin with either multiple daily injections or an insulin pump
- If your insulin regimen requires you to frequently adjust it on the basis of therapeutic CGM testing results.
- The system must be defined as therapeutic CGM which means that you can make treatment decisions using the device and that is why the only one available for coverage under Medicare is the Dexcom G5 Mobile system because it is the only one approved by the FDA to meet the criteria for therapeutic CGM.
Coverage is effective for claims with dates of service on or after January 12, 2017.
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Medicare Coverage Of Cgm
Medicare has provided coverage for CGM systems since 2017, provided they are classified as therapeutic devices, meaning users can use them to make treatment decisions. These include things like changes to exercise regimen, diet or insulin dosage. While thats still the case, The Centers for Medicare & Medicaid Services have recently relaxed Medicares other coverage criteria somewhat. Previously Medicare coverage of CGM devices was limited to patients who met the following requirements:
Have a diagnosis of either type 1 or type 2 diabetes
Use a traditional blood glucose meter and test blood sugar levels four or more times a day
Are treated with insulin injections or insulin pump
- Require frequent adjustments to their insulin regimen
Have an in-person visit with a doctor to evaluate glycemic control and whether they meet the above criteria, as well as follow up appointments every 6 months after prescription
So whats changed? No longer are insulin injections the only acceptable form of insulin administration for those who are covered. Now, diabetics who are treated with inhaled insulin will be eligible for coverage. Additionally, the requirement for self-testing up to four or more times a day with a fingerstick test has been removed, so diabetics who test less frequently may also be eligible.
What Is Freestyle Libre
FreeStyle Libre is a continuous glucose monitoring system that allows a person to check their blood sugar in real-time without having to prick their finger.
The system has two components: a glucose sensor that the person applies to the skin and a digital reader. A person can apply the sensor to the back of their upper arm and leave it in place for a maximum of 14 days.
The sensor monitors a persons blood glucose by measuring glucose levels in the interstitial fluid, which is the fluid between the cells and the blood vessels. A person can hold the digital reader over the sensor to obtain a blood glucose reading.
What Is The Average Cost Of A Cgm Device
The out of pocket costs of CGM devices can be significant, much more than traditional blood glucose monitoring systems. Depending on what model and features you need, you will have to get prescriptions for several different items and purchase them at a retail pharmacy if you dont have insurance coverage. These can include multiple sensors, a transmitter, and receiver. Some models work in conjunction with a smartphone you may already have, in which case you wouldnt need a receiver, like the Dexcom G6. With the Dexcom G6 system, the average retail cost for enough transmitters and sensors for one full year is $6000, or $500 per month! Thats quite a cost prohibitive barrier for a lot of people. This new coverage change announced by Medicare, as well as the continued expansion of private insurance coverage, is good news for diabetics who could benefit from the convenience and improved outcomes possible though the use of CGM devices.
*Please note this information is based on what has been shared publicly, but may not be totally comprehensive. Its important to consult your health plan and your healthcare provider directly.
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Medicare Eligibility For A Therapeutic Cgm
A therapeutic CGM is a medical device approved by the U.S. Food and Drug Administration as a replacement for home blood sugar monitors. It provides you and your doctor with the medically necessary information to make diabetes treatment decisions, such as changes in diet and your insulin dosage.
To qualify for a therapeutic CGM, you must be undergoing treatment for diabetes and meet certain other criteria.
To be eligible for a therapeutic CGM under Medicare, you must meet the following requirements.
- You are using insulin to treat Type 1 or Type 2 diabetes.
- You need to check your blood sugar four or more times per day.
- You must use an insulin pump or receive three or more insulin injections per day.
- You must make routine, in-person visits to your doctor.
- Your doctor has determined that you meet all Medicare eligibility requirements.
The decision between a therapeutic CGM or a traditional monitor is one you should make after talking to your doctor. A therapeutic CGM may be a better option if you use insulin and frequently change your dosage.
What Are The Benefits Of The Freestyle Libre
Compared to traditional glucose monitors, the FreeStyle Libre offers numerous advantages, such as:
- Less need for finger sticks
- Easy placement of patches
- Improved accuracy with over-the-counter medications like acetaminophen
- Fast results any time of the day
- Simpler monitoring
- Improved tracking with trends for the last eight hours displayed
- Prompt notification of out-of-range readings with alarms
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How Does Cgm Work
With CGM devices, patients, caregivers and healthcare providers can identify patterns in behavior, diet, and blood glucose levels that would otherwise be impossible to see. A CGM device operates via a small water resistant glucose sensor that is placed just below the surface of the skin and held in place with an adhesive patch. These sensors can be worn up to 14 days continuously, usually on the torso or upper arm, transmitting blood glucose levels to a reader every few minutes. Thats a lot of data! More information equals more efficient diabetes management. Continuous glucose monitoring systems have been shown to be better at helping people with Type 1 diabetes lower their HBA1C as compared to traditional self-monitoring.
It is much easier to predict and potentially head off hypoglycemia and hyperglycemia events when you can see where blood glucose levels are headed in advance. This is especially true for those with erratic blood glucose levels, hypoglycemic unawareness, children who cant self-monitor, and others.
Use Of Outdated And Inappropriate Evidence Is The Fatal Flaw In Policy Decision
As demonstrated in the REPLACE and DIAMOND T2D studies, use of CGM in individuals with T2D who are treated with intensive insulin management confers significant clinical benefits. Moreover, our subgroup analyses showed no association between baseline SMBG frequency and outcomes.
Why, then, do so many payers continue to restrict CGM use only to individuals with T1D who test 4 times daily? Moreover, why is there such diversity among payers in their coverage policies? The answer may lie in the evidence used in their decisions and where they are getting it.
Payers often hire for-profit health research and technology organizations for guidance in coverage policy decisions. Their guidance is based on evidence gleaned from the literature. However, these organizations use varying methods for assessing the evidence used in their recommendations. For example, some may use the traditional model of five evidence levels, where systematic reviews and meta-analyses are deemed the highest level and RCTs are considered the second highest. Conversely, the ADA considers SRMAs and RCTs to carry equal weight in grading the evidence used in their clinical guidelines. It is our position that the ADA model should be adopted by all policy decision makers when developing guidance recommendations and coverage policies that impact individuals with diabetes.
Medicare Coverage Requirements For Continuous Glucose Monitoring System
Medicare patients with type 1 and type 2 diabetes on intensive insulin therapy may be able to obtain reimbursement if the following Medicare coverage criteria are met:
- The patient has diabetes
- The patient is insulin-treated with three or more daily administrations of insulin or a continuous subcutaneous insulin infusion pump
- The patient’s insulin treatment regimen requires frequent adjustments based on BGM or CGM testing results
- Within six months prior to ordering the CGM, the patient had an in-person visit with the treating practitioner to evaluate their diabetes control and determine that the above criteria have been met and
- Every six months following the initial prescription of the CGM, the patient has an in-person visit with the treating practitioner to assess adherence to their CGM regimen and diabetes treatment plan.
In order to qualify for Medicare coverage of your Dexcom G6 supplies, Medicare requires that you have a receiver that is compatible with Dexcom G6 Continuous Glucose Monitor and that you use that receiver with your supplies, even if you also use a compatible smart device. Medicare does not cover Dexcom G6 supplies that are only used with a smartphone or other mobile device.
Medicare covers Dexcom G6 for insulin-requiring patients who meet the Medicare coverage criteria. For the full list of Medicare coverage criteria, visit the Centers for Medicare and Medicaid services website.
Is Cgm Use Appropriate For People With Non
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Click here to read the Cover Story, “As diabetes technologies advance, matching patients to the right device challenges providers.”
CGM should be used in every diabetes education program for newly diagnosed patients.
I tend to agree with most of my colleagues and say the way glucose monitoring is currently used, it has no value in this population. The data have no value unless they are perceived as actionable information that is reviewed by someone who knows what to do with the numbers. That is the issue.
It is true that most people with type 2 diabetes, especially if they are on medications that are not putting them in danger meaning putting them at risk for hypoglycemia will not need to have glucose numbers flashing all the time. However, CGM offers an opportunity for the person with diabetes to check in with themselves and, ideally, with a health care provider, to look at a variety of things. Am I on the right medication, and is it working? Do I have an opportunity to learn what I need to know to manage my diabetes effectively?
William H. Polonsky
William H. Polonsky, PhD, CDE, is president of the Behavioral Diabetes Institute and an associate professor at the University of California, San Diego. Disclosure: Polonsky reports he has served as a consultant for AstraZeneca, Dexcom, Eli Lilly, Intarcia, MannKind, Merck, Novo Nordisk and Sanofi.
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Study Shows Continuous Glucose Monitors Improve Management Of Type 2 Diabetes
For patients with type 2 diabetes treated with basal or long-acting insulin, the use of continuous glucose monitors can result in significantly lower hemoglobin A1C , and better management of the disease, according to a study recently published in JAMA.
Vanderbilt University Medical Center was one of 15 recruitment centers in the United States for the randomized clinical trial in which researchers compared the effectiveness of traditional finger-stick monitoring to the use of continuous glucose monitors. The eight-month study followed 175 participants with type 2 diabetes on basal insulin who received their diabetes care from a primary care clinician.
Shichun Bao, MD, PhD, associate professor of Medicine, led the effort at VUMC. Bao also leads a Diabetes Technology Program at the Vanderbilt Eskind Diabetes Clinic, where she guides patients on how to better use devices such as CGMs and insulin pumps to improve diabetes management.
Im not surprised by the results, Bao said. Everybody with diabetes would benefit from using these technologies. And one big strength of this study is the involvement of the participants primary doctors. We didnt manage the participants diabetes we collected the data. We talked on the phone with the patient every two months and sent a report to their primary care providers to share their patients CGM data. The patient saw it, and the primary care provider saw it, and that triggered improvement.
How Accurate Is Cgm12
CGM has been available since 2004, but ease of use has improved in the last few years. CGM devices require finger stick calibrations to maintain their accuracy. Many newer devices are factory-calibrated which allows them to maintain their accuracy without finger stick calibration.
If blood sugar is rising or falling quickly, there can be a lag time between glucose concentration readings from CGM and BGM. The glucose level in the interstitial fluid trails slightly behind the glucose level in the capillary which is where a finger stick glucose is checked. There can be a difference after eating a meal or if glucose is falling quickly. Newer devices are factory-calibrated and their algorithms take into account the lag time which helps maintian more accurate readings.
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How To Learn More
- For more information on all of the options available under Medicare, visit: www.medicare.gov or call 1-800-MEDICARE . Also look for the Medicare and You handbook which Medicare mails to beneficiaries in the fall and is available by calling 1-800-MEDICARE .
- To read more about Medicare coverage of diabetes services and supplies, go to .
- For information from Medicare on how individuals might be able to get help paying Medicare costs visit www.medicare.gov/your-medicare-costs/help-paying-costs/get-help-paying-costs.html or call 1-800-MEDICARE .
- Free health insurance counseling and personalized assistance for Medicare beneficiaries is available in every state through the State Health Insurance Assistance Program . Call 1-800-MEDICARE or visit www.shiptacenter.org to find the telephone number of the SHIP office closest to you.
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