CMS Announces Critical First Step Toward Medicare Coverage of CGM
By Helen Gao, Lynn Kennedy, and Adam Brown
CGMs with an insulin-dosing claim, like Dexcom’s G5, finally have a path to Medicare reimbursement; possible coverage in 2018 or earlier
Late last night, in very exciting news, the US Centers for Medicare and Medicaid Services (CMS) took the first key step toward eventually reimbursing certain continuous glucose monitors (CGMs) for people with diabetes.
Under the new CMS ruling, CGMs that are FDA-approved for making diabetes treatment decisions (e.g., dosing insulin) finally have a pathway to Medicare reimbursement – in formal terms, this means they have what’s called a “benefit category.” Dexcom’s G5 CGM is currently the only device in the US with this indication, having received FDA approval in December.
Dexcom will now work with CMS over “the coming months” to implement coverage, enabling those on Medicare to finally get CGM reimbursed. While yesterday’s news came about six to nine months earlier than expected, the exact timeline for the implementation of coverage is not yet clear. Dexcom previously expected coverage in 2018, but given the early ruling, diaTribe wonders if G5 reimbursement through Medicare could even come as early as later in 2017.
To be clear: this does not mean that Medicare is paying for CGM devices today. But, it does mean that a huge stumbling block has now been cleared, opening the door to coverage for the first time ever.
News of this first step towards Medicare coverage of CGM reflects years of powerful and sustained patient advocacy. According to the JDRF, who has worked with a laser-beam focus toward this decision on many fronts, the CMS ruling was “more than a decade in the making.” Most recently, JDRF was very active with a slew of other diabetes advocacy organizations at a June 2016 FDA Advisory Committee meeting for Dexcom’s G5.
At the meeting, over 35 patient advocates shared compelling testimonies about the benefits of CGM, along with dozens of healthcare providers, diabetes researchers, and big advocacy organizations (JDRF, AACE, ADA, and the Endocrine Society). Two major petitions in favor of dosing insulin with CGM were also given to FDA; a dosing claim for Dexcom’s G5 was necessary to get to this decision with Medicare. Patient voices were loud and clear – huge thanks goes out to the over 10,000 people with diabetes and their families who signed the letter written by The diaTribe Foundation that made clear to the FDA how important insulin dosing is to CGM users. The culmination of all that work was the December FDA approval of a dosing claim for Dexcom’s G5. With yesterday’s ruling, Dexcom’s G5 is now very close to actual Medicare coverage.
This news is a major win for hundreds of thousands of people with diabetes covered under Medicare, for whom severe hypoglycemia is more likely and for whom CGM could be life-saving.
Looking for more information? Read on for more details and answers to FAQs!
What will be reimbursed? How much will I have to pay?
Based on the CMS ruling, it appears that Medicare will provide reimbursement for:
The receiver for viewing real-time glucose data;
Four sensors per month;
And the cost of BGM and test strips for calibrating the Dexcom G5 twice per day.
Under Medicare Part B – which is what will cover Dexcom’s G5 – recipients are typically responsible for 20% of the cost. Based on the CMS ruling, people with diabetes might be responsible for a one-time cost of $47 to $55 for the receiver (three-year use) and ongoing costs of $50 per month total for sensors, transmitters, and other accessories. Costs may vary based on different supplemental insurance; this article will be updated as more is learned.
Will Medicare cover other CGM devices besides Dexcom’s G5?
To qualify under Medicare, a CGM will need to be FDA-approved for making diabetes treatment decisions, specifically dosing insulin.
Medtronic CGM devices currently do not have this label (including the just-approved Guardian Sensor 3 with the MiniMed 670G), so will not qualify for Medicare coverage.
Abbott’s FreeStyle Libre (real-time, consumer version) does not require fingersticks and is currently under FDA review. It is not yet clear if the FDA will approve it for making diabetes treatment decisions. If it does secure a similar approval as Dexcom’s G5, diaTribe assumes it will also qualify for Medicare reimbursement (although what sort of approval it could receive and when is unknown).
Will Medicare cover CGMs for both people with type 1 and type 2 diabetes? Do I need to be taking insulin to qualify?
The language of the ruling suggests that all people with diabetes will be eligible for reimbursement under Medicare – type 1s, type 2s, and insulin and non-insulin users. diaTribe is not positive and will have to see what happens once the coverage rolls out.
What happened at the FDA meeting that led to this decision?
To watch clips from the Open Public Hearing and panel vote that led to this CMS decision, visit diaTribe’s video archive – The diaTribe Foundation was onsite at the FDA and got special permission for this to be the first FDA meeting to use Facebook Live! diaTribe’s very own Adam Brown had a very memorable speech here – see his slides here, as well as Kelly Close's slides here and talking points here, Ava Runge's slides here (she heads up advocacy efforts at The diaTribe Foundation), and 15-year-old Caroline Dorn's talking points here (she was one of the five speakers The diaTribe Foundation brought to the meeting) – all have diabetes and joined with over 30 other people with diabetes, physicians, nurses, and researchers speaking in favor of the FDA allowing people with diabetes to use Dexcom for insulin dosing.
What is not yet known?
It is not clear exactly when coverage will begin or how much hassle it will be to access CGM for those on Medicare. Updates from Dexcom and from CMS should clarify this in coming months – stay tuned!
Thank you tremendously to so many scientists, researchers, physicians, nurses, business leaders, people with diabetes, and their families for so much work on this over so many years. We are excited for this technology to be covered so that as people with diabetes, we can work to keep ourselves as safe and healthy as possible!