The diabetes community is rejoicing over today’s announcement that the U.S. Centers for Medicare & Medicaid Services (CMS) have published new criteria for covering the Dexcom G5 Mobile CGM (continuous glucose monitoring) system for all people with diabetes on intensive insulin therapy. This decision comes after years of hard work, rigorous studies and advocacy by many stakeholders, including representatives from industry, health care, patient advocates and non-profits like T1D Exchange.
What It Means
With today’s announcement, the Dexcom G5 CGM system will now be covered by Medicare/Medicaid under the Durable Medical Equipment (DME) code for people who meet the following criteria:
- 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 beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results.
Until recently, CGM had been classified as an adjunctive device, meaning that it complemented care, and thus, didn’t fit into a category that Medicare would cover. But in January 2017, CMS announced they would recognize a recent FDA decision that classified CGM as durable medical equipment and today published an article detailing this new criteria with retro-active coverage for claims with dates of service on or after January 12, 2017.
T1D Exchange’s Impact
As we recently shared in our article, “Power to the People! How the Voice of People with T1D Can Influence Regulatory Decisions,” T1D Exchange played a significant role in providing patient-driven evidence to support this ruling.
- the REPLACE BG study: A trial comparing continuous glucose monitoring (CGM) with and without routine blood glucose monitoring (BGM) in adults with type 1 diabetes. This study was recently published in Diabetes Care following a presentation at the 10th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) earlier this month in Paris. The results of this study supports the use of CGM for treatment decisions as safe and effective as blood glucose monitoring!
- Hypoglycemia in Older Adults: The FDA also received the data from two T1D Exchange studies analyzing hypoglycemia in older adults. These analyses found that 21% of people over the age of 65 who had T1D for more than 40 years reported seizures or loss of consciousness due to a severe hypoglycemic episode—a percentage far greater than what was previously understood.
Additionally, the Glu community also helped provide valuable insight. In December of 2016, we asked two Questions of the Day that were used to supplement the evidence being presented. (For more detail on these studies and questions, click here). All of these research projects provided significant and relevant evidence that supported the FDA decision, which has directly led to today’s news from CMS to improve device access for older people living with type 1 diabetes.
“We are grateful that organizations such as T1D Exchange recognize the need to build evidence around the safety and efficacy of CGM use in treatment decisions,” says Kevin Sayer, president and chief executive officer of Dexcom.
A Huge Step Forward
We are elated that CMS has made this important decision to cover the Dexcom G5 CGM system for its Medicare and Medicaid patients, and are proud that our work in type 1 diabetes research has made an impact.
Our important work couldn’t happen without your support – both online at Glu, through other T1D Exchange programs. As a 501©3 non-profit organization working to improve outcomes for people with type 1 diabetes, we can’t provide this critical data and impact change without financial support from this community. Please consider supporting T1D Exchange research with a donation today.