Medicare Requirements For Continuous Glucose Monitoring

How Much Does It Cost To Get An Insulin Pump

Medicare Now Covers Continuous Glucose Monitors!

Medicare covers 80% of the Medicare-approved cost of insulin pumps. You are responsible for the other 20%, plus the Part B deductible and monthly premiums.

Your pump must be prescribed by a Medicare-approved physician and purchased or rented from a Medicare-approved medical supplier for Medicare to cover it.

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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

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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.

How Do I Get Medicare To Cover A Cgm

Medicare should permit its beneficiaries who use continuous glucose ...

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 doesnt

Medicare Now Covers Abbotts Freestyle Libre Cgm

Available to people with type 1 or type 2 diabetes on intensive insulin therapy. Another continuous glucose sensor option for people over 65 is now covered, in addition to Dexcom G5!

This just in: Medicare will now cover Abbotts FreeStyle Libre real-time continuous glucose monitoring system. The news came in much faster than we had expected, only three months after the FDA approved the no-calibration FreeStyle Libre as a replacement for fingersticks and safe for dosing insulin. This also came quite fast after FreeStyle Libre launched last month in retail pharmacies in the US.

Starting today, those on Medicare with type 1 or type 2 diabetes using intensive insulin therapy now have access to two CGM systems: Abbotts FreeStyle Libre and Dexcoms G5. The criteria for FreeStyle Libre coverage is identical to that for Dexcoms G5. That is, someone covered by Medicare is eligible for reimbursement for either device if he or she:

Has type 1 or type 2 diabetes
Currently uses a home blood glucose monitor and performs at least four fingersticks per day
Takes insulin, either with multiple daily injections or an insulin pump
And has an insulin plan that requires frequent changes based on CGM readings.

As diaTribe understands it, Medicare will cover the following FreeStyle Libre components for those eligible :

More Details and FAQ:

Cms Expands Medicare Coverage For All Cgms

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CMS will expand Medicare coverage for all types of continuous glucose monitors, including adjunctive and non-adjunctive CGMs.

The final rule, issued Dec. 21, classifies adjunctive CGMs under the Medicare Part B benefit for durable medical equipment and finalizes certain DME payment provisions that were included in two interim final rules. It will be effective starting 60 days after official publication.

The Durable Medical Equipment, Prosthetics, Orthotics and Supplies final rule aligns with the key goals of the administration to create a health care system that results in better accessibility, quality, affordability, empowerment and innovation, CMS stated on its web site.

In a fact sheet, noted it is not finalizing the proposed categories of supplies and accessories and fee schedule amounts for three types of CGM systems.

After consideration of public comments, CMS does not believe it is necessary at this time to further stratify the types of CGMs beyond the two categories of non-adjunctive and adjunctive CGMs, the agency stated. The fee schedule amounts for the newly covered adjunctive CGMs and related supplies and accessories will be established in accordance with existing regulations for establishing fee schedule amounts for new durable medical equipment items and services without a fee schedule pricing history at 42 CFR 414.238.

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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.

Why Medicare Will Cover The Medtronic Cgm Now

Dexcom G6 Medicare Patient Coverage

Up until now, Medtronic has been the only CGM company without Medicare coverage.

The other CGM products available Dexcom G5 and G6, Abbott FreeStyle Libre 2, and the implantable Eversense CGM from Senseonics and Ascensia have been covered for years. But Medtronic is the only company that did not get a non-adjunctive designation , which wouldve allowed the CGM to be used for insulin dosing and treatment decisions without a need for confirmatory fingersticks.

That so-called dosing claim was a new category created by the Food and Drug Administration , its first attempt to distinguish the different levels of CGM technology that existed at that time in 2017. The Dexcom G5 was the first to obtain that status and be known as a therapeutic CGM, followed by the Abbott FreeStyle Libre and then Eversense 90-day implantable CGM.

To date, Medtronics Guardian CGM remains the only one that requires fingerstick calibrations and doesnt have Medicare coverage.

But CMS is now changing that, lumping Medtronics device into the same category as the non-adjunctive devices so that they are all covered by Medicare.

Importantly, the new Medicare policy does not include Medtronics stand-alone Guardian Connect CGM system. Instead, it only allows for Medicare coverage of the Medtronic CGM when it is combined with the companys MiniMed insulin pumps.

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Does Medicare Cover Diabetic Sensors

Diabetic sensors are also referred to as glucose sensors. Theyre used to measure blood sugar as part of a CGM system. Medicare does not cover every CGM system. If your system is covered, your diabetic sensor will be, too.

Diabetic sensors are professionally inserted under the skin, usually on the abdomen or arm. They take continual glucose measurements, which you can monitor at a glance. You can share your readings with a mobile device, such as your smartphone.

Are you eligible for cost-saving Medicare subsidies?

Order The Freestyle Libre 2 System Starter Kit From Ehcs*

Ready to get started with the FreeStyle Libre 2 System? Order the starter kit, which includes the FreeStyle Libre 2 reader and two FreeStyle Libre 2 sensors. *The FDA requires a prescription for the FreeStyle Libre 2 System.

Sensor is water-resistant in up to 1 meter of water.

* Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 hours. Reference: 1. FreeStyle Libre 2 Users Manual.

**Please refer to www.FreeStyleLibre.us for the indications and important safety information.

EHCS-FSL2-01

Billing For Continuous Glucose Monitor

On December 28, 2021, the Centers for Medicare & Medicaid Services published a final rule which was implemented on February 28, 2022. This final rule addressed the classification and payment of continuous glucose monitor under the Medicare Part B benefit for durable medical equipment . This rule expanded the classification of DME to a larger group of CGMs, regardless of whether the CGMs are non-adjunctive or adjunctive . As such, claims for adjunctive CGMs and related supplies and accessories can now be covered under the Part B DME benefit category when the system meets the DME definition.

New Medicare Coverage Requirements Make Cgms More Accessible

The diabetes community is celebrating a huge win! Beginning on July 18, 2021, Medicare will permanently eliminate the requirement of the four-time-daily fingerstick in order to qualify for coverage of a continuous glucose monitor .

This requirement was an unnecessary barrier for Medicare beneficiaries, delaying access to this effective technology for individuals with diabetes.

CGMs provide users with real-time, dynamic information about their blood glucose levels around the clock and alerts to prevent dangerous high or low glucose levels, leading to better diabetes management and ultimately improved health outcomes. One out of five people on Medicare have diabetes, and the elimination of the fingerstick requirement means Medicare beneficiaries with diabetes will have easier access to this critical technology.

What does this mean for you? If you already have coverage for your CGM, great! If youre looking to get one and receive your health insurance through Medicare, after July 18 there will be a simplified, fingerstick-free approval process. The out-of-pocket cost for your CGM will depend on a few factors, like what your Medicare benefit plan looks like, where youll get your device, etc. Talk to your doctor and a Medicare representative to determine what it will cost for you.

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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 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 Chicagos 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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Big Changes Centers For Medicare & Medicaid Services Loosen Requirements For Obtaining A Continuous Glucose Monitor During Covid

In-person visits, lab tests, and finger stick documentation are no longer required at present to get a CGM

Editor’s note: This article was updated on May 21, 2020 to reflect that lab testing is still required for an insulin pump and pump supplies.

High blood sugar levels leave the body vulnerable to infections, meaning those individuals with poorly controlled diabetes are at greater risk of contracting COVID-19. To properly monitor and respond to glucose levels and to strengthen the immune system to fight off infections, a continuous glucose monitor can be very helpful.

If you are on Medicare, obtaining a CGM through your healthcare professional is a relatively involved process, requiring an in-person clinic visit, lab tests, documentation of frequent finger sticks , and a lot of paperwork. At present, only those on insulin have an opportunity for approval. However, due to COVID-19 and the increased risks it poses for people with diabetes, the Centers for Medicare & Medicaid Services announced that it will not enforce the following criteria for receiving a CGM:

In-person clinic visits
Clinical criteria, including lab tests for C-peptide or auto-antibodies, or demonstration of frequent finger sticks

We hope that in the future, at least those on SFUs will be able to get CGM, as SFUs can prompt hypoglycemia, which is especially dangerous right now, given the importance of staying out of the hospital.

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

Will Dexcom’s G7 Continuous Glucose Monitor be 60% Smaller Than the G6?

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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