Medicare Announces Criteria Covering Dexcom G5 Mobile CGM for All People with Diabetes

press release

March 24, 2017

Medicare Announces Criteria Covering Dexcom G5 Mobile CGM for All People with Diabetes on Intensive Insulin Therapy

SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) for people with diabetes, is pleased to announce that the U.S. Centers for Medicare & Medicaid Services (CMS) has published an article clarifying criteria for coverage and coding of the Dexcom G5 Mobile system, the only therapeutic CGM under this CMS classification. People covered by Medicarewho have either Type 1 or Type 2 diabetes and intensively manage their insulin will now be able to obtain reimbursement.

"This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM," said Kevin Sayer, President and Chief Executive Officer, Dexcom. "This decision supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age."

According to CMS, therapeutic CGM may be covered by Medicare when all of the following criteria are met:

• The beneficiary has diabetes mellitus; and,
• The beneficiary has been using a home blood glucose monitor (BGM) and performing frequent (four or more times a day) BGM testing; and,
• The beneficiary is insulin-treated with multiple daily injections (MDI) of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,
• The patient's insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results.

In order to be included in this category, the system must be defined as therapeutic CGM, meaning you can make treatment decisions using the device. Dexcom G5 Mobile is the only system approved by the FDA to meet that criteria.

The entire release can be found here

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Decision Moves Continuous Glucose Monitors One Step Closer to Medicare Coverage

great news from JDRF.org !!

January 12, 2017

Continuous glucose monitoring (CGM) devices approved by the FDA for use in making diabetes treatment decisions are durable medical equipment, according to a decision today by the Centers for Medicare & Medicaid Services (CMS). That determination removed a major roadblock to the devices’ coverage under Medicare. Today’s decisions mean that CGMs approved by the FDA for use in making diabetes treatment decisions are eligible for reimbursement under Medicare.

Today’s decision creates a pathway for Medicare coverage for the devices that will bring the nation’s largest insurer in line with the vast majority of the country’s private payers. Although the significant benefits of CGM use have been known since 2008, CMS had previously refused to consider covering the devices under Medicare, saying they did not meet the statutory definitions of durable medical equipment or any other category the agency could cover. Today’s decision removes that impediment.

“JDRF is encouraged by this decision, which will bring us closer to Medicare coverage for continuous glucose monitors,” said Aaron J. Kowalski, PhD, JDRF’s Chief Mission Officer. “I want to thank the tireless JDRF advocates and Congressional champions who have made this progress possible.”

the entire press release can be found here on the JDRF website

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Dexcom G5 Mobile Gains Apple Watch Complications!

Do you know what watch complications are? 

Complications are the newest feature for the Apple Watch app. Dexcom G5 users with an Apple Watch can choose from 4 different watch faces and by just lifting their wrist they can quickly and easily see their glucose level and trend arrow.

“Complications are small visual elements on the watch face that communicate important information to the user. The term complication comes from watch making, where the addition of features added complexity to the watch construction. Complications are visible whenever the user looks at the watch face, and users can customize which complications are displayed. The number of slots available for complications on a given watch face varies, but most support at least two or three complications.”

— Apple Developer Website

Dexcom representatives told me....

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"We have seen many social media posts indicating that our users have purchased the Apple Watch primarily because Dexcom CGM glucose data is available on the watch. We are excited that this release will allow our users with an Apple Watch even greater convenience for those who want this important information in an easy-to-use and discreet form."

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"Close collaboration took place with Apple to get the watch platform to support our use case of 288 updates/day to make this feature possible for CGM. The Dexcom Watch Face was shown at last year’s World Wide Developers Conference in September, and its currently being promoted on Apple’s website in two locations, (1) on great new features of watchOS3, and (2) third-party ecosystems that make the Apple Watch great. Below are screenshots from both of Apple’s website locations."

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"As part of Dexcom’s commitment of continuous improvement in the quality and user experience of our apps, the 1.6 release also includes several sustaining improvements and enhancements."

Dexcom apps are available for iOS here. 

Click here to learn more about Dexcom

Dexcom G5 App v1.6 and Apple Watch running watchOS 3 or later required. US only.

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FDA: No Fingerstick Needed with Dexcom G5 CGM

from: MedPage Today

by John Gever
Managing Editor, MedPage TodayDecember 20, 2016

WASHINGTON -- The FDA has approved an expanded indication for Dexcom's G5 Mobile continuous glucose monitor, allowing it to be used alone without supplementary fingerstick glucose testing.

"This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test," the agency said in announcing the decision. Previously, the system had been approved as an adjunct to fingerstick testing.

But the new approval does not mean patients can forget about fingerstick testing entirely. "Users are warned that the system must be calibrated using a fingerstick blood sample at least once every 12 hours," the FDA stressed.

In deciding to expand the indication, the FDA relied on findings from two 7-day clinical trials involving a total of 130 adults and children as young as 2. Results from the continuous monitor were compared with those from standard fingerstick meters and from lab tests of blood glucose. Those studies indicated that the continuous monitor was accurate enough to be used alone to guide treatment.

The FDA noted that the device still comes with risks including hyper- and hypoglycemia stemming from inaccurate readings. Also, redness and irritation may occur at the site where the device's skin patch is applied.

The agency also indicated that acetaminophen-containing products can "falsely raise glucose readings" from the device.

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Health Canada approves Dexcom G5 for dosing

Look at Canada leading the way... We don't usually see this. Very exciting... congrats to all of my Canadian readers!

press release from PR Newswire

With Health Canada approval, Dexcom G5® Mobile CGM System is the First and Only Medical Device in North America for Making Daily Diabetes Decisions Without Painful Fingersticks

Landmark approval marks a new standard of care for managing diabetes and dosing insulin in Canada

BURNABY, British Columbia, Nov. 14, 2016 /PRNewswire/ -- Dexcom, Inc. (NASDAQ:  DXCM), the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that Health Canada has approved its Dexcom G5 Mobile CGM system for "non-adjunctive" use by people with diabetes aged 2 years and older. 

The "non-adjunctive" indication enables the use of the Dexcom G5 Mobile CGM system as a replacement to fingerstick glucose testing for diabetes treatment decisions, making it a significant new standard of care in diabetes management. This approval means that diabetes patients and their physicians can now make treatment decisions based on data reported by the Dexcom G5 Mobile CGM system alone, without the use of painful fingersticks associated with blood glucose meters (fingersticks are only needed every 12 hours to calibrate).  With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system that sends glucose data directly to a smart device, freeing users from the need to carry a separate receiver.  The device transmitter securely sends vital glucose information every five minutes directly to an app on iOS-enabled devices for real-time diabetes management. Users of the system can also select up to five designated recipients, or "followers" so they can remotely monitor the user's glucose information and receive alert notifications for added protection and peace of mind.

"News of the Canadian launch of the Dexcom G5 Mobile CGM System is truly exciting.  CGM technology allows people with diabetes to view real time glucose data and trends, and the built-in alarms allow for intervention by the user to minimize the risk of hypoglycemia and hyperglycemia. It has become an invaluable component of diabetes management, especially for pediatric patients," said Dr. Angelo Simone, Pediatric Endocrinologist, Trillium Health Partners, Assistant Professor, Department of Pediatrics, University of Toronto. "As a Pediatric Endocrinologist I look forward to being able to review my patient's glucose data even before the family arrives in clinic."

"As a country singer, a pilot and a person living with diabetes, I benefit tremendously from the glucose readings that I get every 5 minutes from my Dexcom CGM," says George Canyon, Canadian Country singer and type 1 diabetic. "Now, seeing my glucose levels on my phone will enable me to manage my diabetes even better and do all the things that I love most without the inconvenience and pain of fingerstick testing  multiple times a day, it's like a whole new world." 

Before the landmark approval by Health Canada, the Dexcom system could only be used to augment glucose meter fingerstick testing.  Canada is the first country in North America to approve the device with the non-adjunctive indication as a U.S. Food and Drug Administration (FDA) Advisory Panel voted in favor of granting a non-adjunctive claim in the U.S. this summer but a final FDA decision is still pending.

"The new indication in Canada for the Dexcom G5 Mobile CGM system is an astounding milestone for people with diabetes and is a critical step forward for advancing diabetes technology to drastically change diabetes management," said Kevin Sayer, Dexcom President and Chief Executive Officer. "Now, people with diabetes in Canada who use the Dexcom G5 Mobile CGM system can make treatment decisions without having to perform multiple fingersticks daily, which has posed a significant barrier to properly managing diabetes in the past."

The Dexcom G5 Mobile CGM System will be available within the first three months of 2017.

The entire press release can be found here.