Thursday, November 24, 2022

Are Continuous Glucose Monitors Covered By Medicare

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Which Cgm Devices Are Covered By Medicare

Medicare Now Covers Continuous Glucose Monitors!

The Dexcom G5 was one of the first of the CGM devices to be FDA approved as a therapeutic CGM in 2017, which qualified the device for Medicare coverage. As with most other technology, diabetes technology continues to evolve, and newer products have since followed suit, including those manufactured by Abbott, Medtronic, and others.

Currently, Aeroflow offers the Dexcom G6, the FreeStyle Libre 14 Day System and the FreeStyle Libre 2, all eligible for Medicare coverage. The Dexcom devices are typically worn on the skin of the torso for up to 10 days, where a water resistant sensor can measure and transmit blood glucose readings every few minutes to a reader or a smartphone app. The FreeStyle Libre is a line of continuous glucose monitors that are typically worn on the skin of the upper arm for up to 14 days. Unlike the Dexcom, the FreeStyle is a flash glucose monitoring system, meaning that while it continually measures blood glucose levels, it only transmits this to a reader when scanned. Each has its own set of unique features, alarms, and recommended age range.

Does Medicare Cover Continuous Glucose Monitors

Original Medicare covers continuous glucose monitors through Part B of Medicare. In most cases, Medicare covers the monthly supplies for a monitor, which is a combination of sensors, transmitters and batteries depending on the brand. Although devices are covered, beneficiaries may have to pay copays or deductibles.

As Medicare Advantage must provide the same level of coverage as Original Medicare, these devices are also available to people on Medicare Advantage Plans. However, individual Medicare Advantage Plans may have different rules around costs, brands and the choice of where you can get services.

In the past, continuous glucose monitors were considered precautionary instead of medically necessary, which limited the number of people who could gain access to the technology. However, rules changed in 2021, allowing more enrollees to benefit from the devices.

Is Dexcom Covered By Medicare

Does Medicare cover Dexcom G6?

Yes. The Dexcom G6 Continuous Glucose Monitoring System is covered by Medicare for patients who meet the Medicare coverage criteria. Medicare coverage for therapeutic CGM includes certain beneficiaries who have either type 1 or type 2 diabetes and intensively manage their insulin. Dexcom now ships Dexcom G6 to Medicare patients with traditional fee-for-service coverage. For a full description of coverage criteria, .

Medicare Coverage Criteria

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.

*To view a list of compatible smart devices, visit dexcom.com/compatibility

I am an existing Medicare customer. How do I get my ongoing Dexcom G6 supplies?

CMS Policy

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Therapeutic Continuous Glucose Monitors

Medicare covers therapeutic continuous glucose monitors and related supplies instead of blood sugar monitors for making diabetes treatment decisions, like changes in diet and insulin dosage.

If you use insulin and require frequent adjustments to your insulin regimen/dosage, Medicare may cover a continuous glucose monitor if your doctor determines that you meet all of the requirements for Medicare coverage.

What Are The Qualifications For Medicare Coverage For Cgms

NEWS: Medicare to Cover Some Continuous Glucose Monitors

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.

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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.

References

Medicare To Cover Therapeutic Cgm Sets Criteria

For Medicare patients on continuous glucose monitoring , the news is good. The Centers for Medicare and Medicaid Services will cover therapeutic continuous glucose monitoring , and have set the criteria that must be met. In the past, it has not been covered.

CMS announced the criteria decision March 23, following their January ruling about granting coverage for CGM. 1

The coverage decision ”is a game changer for our Medicare patients,” says Amy Hess-Fischl, MS, RD, LDN, BC-ADM, CDE. She is program coordinator for the Teen and Adolescent Diabetes Transition Program at the University of Chicago’s Kovler Diabetes Center and a member of the editorial board for EndocrineWeb.

The decision is ”long overdue,” says J. Michael Gonzalez-Campoy, MD, PhD, medical director and CEO of the Minnesota Center for Obesity, Metabolism and Endocrinology in Eagan, MN, and a member of the editorial board for EndocrineWeb. “The medical literature clearly documents that enhanced monitoring improves outcomes in the treatment of diabetes.”

The coverage is effective for service dates Jan. 12, 2017 and later, according to CMS.

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Medicare And Cgm Coverage

When the food and drug administration gave the green light for people to make dosing decisions based on CGM results, Medicare began covering CGMs. The decision was put into effect in January 2017. The coverage ruling saves people between $2,500 to $4,000 a year who might otherwise purchase the equipment out of pocket. Michael Gonzalez-Campoy, MD, Ph.D., Medical Director and CEO of the Minnesota Center for Obesity, Metabolism, and Endocrinology, claims that based on the studies hes read, CGMs provide the kind of enhanced monitoring that improves diabetes treatment.3

What Are The Benefits Of The Freestyle Libre

Dexcom G6 Medicare Patient Coverage

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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What About Medicare Coverage For Those Not On Intensive Insulin Therapy

At this time, Medicare coverage is only available to those that meet the criteria above. We feel very strongly that others at risk of hypoglycemia, especially those on sulfonylureas , should also have access to CGM. We will be working on advocacy on this front if youd like to help.

If you have other questions on Abbotts FreeStyle Libre, Dexcoms G5, and Medicare coverage,

Medtronics New Access Program Provides Discounted Cgm To Those Without Coverage

Jeemin Kwon

The CGM Discount Access program provides discounted rates on the Guardian Sensor 3 continuous glucose monitoring system for people without insurance coverage for Medtronic CGMs.

Medtronic recently launched its CGM Discount Access program which provides the Guardian Sensor 3 continuous glucose monitor at a discounted price to people who meet the eligibility criteria. Specifically, the program provides a Guardian Link 3 transmitter with a 12-month warranty for $180 and a monthly supply of five Guardian Sensor 3 sensors for $60 per month.

To be eligible for the program, people must:

  • Use multiple daily injections of insulin or be on insulin pump therapy

  • Have a valid CGM prescription from a healthcare professional

  • Not have insurance coverage for a Medtronic CGM

People on Medicare are also eligible for the CGM Discount Access program, as Medicare does not currently cover Medtronics CGM system. It should be noted however, that the Centers for Medicare and Medicaid Services recently proposed new rules that would allow for reimbursement of Medtronics Guardian CGM. If approved, the changes would go into effect on April 1, 2021.

These programs have become increasingly important, especially since people with diabetes face more severe financial hardship during the pandemic. Read more about how COVID-19 has affected the diabetes community here.

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New Rules: Medicare Now Extends Coverage Of Cgms

Medicares decision to extend coverage to continuous glucose monitoring systems should expand use of the technology and improve glucose control among seniors.

At A Glance

  • Medicare has begun covering continuous glucose monitoring systems, which is leading to more seniors using systems shown to improve glycemic control.
  • There are two FDA-approved systems available that offer different strengths that appeal to different patient situations.
  • CGM can improve glucose control in patients regardless of age or education level, but it requires training to optimize the benefits.

New Medicare rules that extend reimbursement to include continuous glucose monitoring systems are already leading to greater use among the senior population of a technology shown to improve glycemic control, and the trend is expected to grow.

Some patients had been waiting for over two years for these sensors to be covered by Medicare. They are really happy about having access now, says Grazia Aleppo, MD, associate professor of medicine and director of the Diabetes Education Program at Northwestern University, who has moved quickly to introduce patients to the technology. We also have many patients who are happy Medicare started covering therapeutic CGM because they had been paying for it out of pocket.

And although CGM tends to be associated with type 1 patients, the Medicare rules do not differentiate between diabetes types, as the qualifying factor is insulin dependence.

Medicare Coverage Of Cgm

Abbott FreeStyle Libre 14

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.

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Medicare Criteria For Therapeutic Cgms*

  • The beneficiary has diabetes mellitus
  • The beneficiary administers insulin three or more times per day via MDI or inhalation or uses an insulin pump
  • The treatment regimen requires the beneficiary to frequently adjust based on the therapeutic CGM testing results
  • The beneficiary has seen his/her doctor in the last six months

To remain eligible, the beneficiary must see his/her doctor every six months to evaluate the CGM therapy.

Do you qualify? Apply for your CGM Today! Not sure if you qualify, no problem let our team of diabetes care experts assist you through the process.

* as of July 18, 2021

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Cgm Use And Inhaled Insulin

Along with this recent CGM policy change, Medicare has also expanded coverage for inhaled insulin Afrezza.

Originally, Medicare would not pay for both Afrezza and CGM technology, meaning that someone wanting to use either of these for their diabetes management would have to choose.

The restriction was in the fine print. Medicare documentation previously defined insulin users only as people using either multiple daily injections or using an insulin pump. But this policy change requested by Afrezza-maker MannKind Corp. has now amended the definition to include someone taking an inhaled insulin as an alternative.

This is a win-win for Medicare patients and providers that serve those patients, said Dr. Stella Ilyayeva, an endocrinologist in New York. In 2020, almost two-thirds of T1D Afrezza patients were utilizing a CGM concomitantly. I anticipate this change will open up more doors for the population of Afrezza users.

This rule change also takes effect on July 18, 2021.

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How Do I Get Medicare To Cover A Cgm

For Medicare to cover the cost of FreeStyle Libre, you must:

  • Continue to pay your Part B premium
  • Have already paid your Part B deductible
  • Receive a prescription for the device from a physician who accepts Medicare
  • Buy the CGM from a supplier who accepts Medicare
  • Cover whatever portion of the costs that Medicare doesn’t

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Manage Your Diabetes With A Continuous Glucose Monitor From US MED

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Disclaimer

The Eversense® Continuous Glucose Monitoring System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration twice per day, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a Health Care Provider. The Eversense CGM System is a prescription device patients should talk to their Health Care Provider to learn more. For important safety information, see Safety Information.

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What Are The Key Differences Between The Medicare Version Of Freestyle Libre And G5

These product differences will change over time some potentially this year. For instance, Dexcoms next-gen G6 is currently under FDA review, with plans to launch before the end of 2018. It is currently under review for one fingerstick calibration per day and 10-day wear, but FDA discussions are also underway for a no-calibration version. Meanwhile, Dexcoms next-next-gen sensor with Verily requires no calibration, will be fully disposable, and last 10 or 14 days. Abbott is currently developing a next-gen FreeStyle Libre as part of its Bigfoot partnership, which will add continuous communication to the FreeStyle Libre sensor. Wed guess it could add alarms too, but this is speculation on our part.

What Should Providers Do When Contacted By Cms Regarding Their Cgm Device Billing History

With CMS, the HHS OIG, and the DOJ all prioritizing enforcement with regard to Medicare billing for CGM devices, entities that bill Medicare for CGMs need to be prepared for the possibility of an audit or investigation. If contacted by auditors or federal agents, providers, pharmacies, and others should be prepared to:

Identify Relevant Documentation and Initiate an Internal Compliance Audit

Immediately upon learning of an audit or investigation, it is imperative to identify and preserve all relevant documentation. This includes Medicare compliance policies and procedures, patient records, and billing records pertaining to DME and non-DME continuous glucose monitoring devices. An internal compliance audit needs to be conducted at this time as well, as it will be necessary to determine whether auditors or investigators are going to uncover Medicare billing violations.

Establish Clear Lines of Communication and a Chain of Command

All internal personnel should be instructed not to communicate with auditors or agents directly. There should be a clear chain of command, and all communications with federal authorities should be routed through the practices or companys defense counsel.

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Does Medicare Cover Dexcom G6

Glucose monitoring technology, including continuous glucose monitoring systems, plays a vital role in protecting the health of individuals who suffer from issues related to blood sugar and insulin production. In the past, individuals who needed to check their blood glucose levels would typically need to obtain a blood sample, often through a prick on the finger, and the sample would then need to be manually inserted into a testing device for analysis. Unfortunately, this method can be time-consuming, and it relies on the user remembering to take measurements at various times throughout the day. This could also mean missing regular testing during the night due to sleep.

Today, however, advanced glucose monitoring using technology like the Dexcom G6 can provide real-time data 24 hours a day for people who need continuous monitoring. Modern monitoring provides important information regarding overall health as it relates to glucose levels, allowing for faster treatment in the event of an emergency. This is vital for patients who are diabetic or for patients who may be at risk for developing health conditions related to fluctuating or uneven blood glucose.

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