Background: Medicare was virtually the last large insurer not to cover CGM
The type 1 diabetes community achieved a long sought and hard fought victory on January 12, 2017, when the Center for Medicare and Medicaid Services (CMS) announced that it would cover Continuous Glucose Monitoring (CGM). This came after a decision from the Food and Drug Administration (FDA) to approve the Dexcom G5 CGM system for non-adjunctive use; meaning that the Dexcom CGM is approved to directly treat blood glucose without first verifying the result with fingerstick blood glucose monitoring (BGM).
While there are other requirements that also have to be met, this last, not having a non-adjunctive treatment indication from FDA, was cited as the primary reason that CMS could not cover CGM. It was stated by CMS that because CGM results required verification with another device, that its use was regarded as “precautionary,” and therefore not coverable by CMS because they did not have a category for it.
Prior to FDA approval, Medicare was virtually the last major insurer in the US that would not cover a personal CGM device, no matter what the personal circumstance. This stance seemed medically indefensible, and violated the stated policies on CGM from major diabetes organizations like the American Diabetes Association (ADA), Association for Clinical Endocrinology (AACE), and Endocrine Society (ES). T1D Exchange has reported on this before to its Glu community, and some determined individuals were able to get individual coverage by struggling through multiple levels of appeal. But forcing drawn out appeals was not an acceptable solution.
Driven by community need and demand
Many organizations and individuals fought hard for years to change the CMS non-coverage policy, including the T1D Exchange (of which Glu is part). Dexcom made a considerable effort to secure FDA approval for making treatment decisions directly from CGM results. An FDA advisory board meeting in July 2016 on direct treatment from the Dexcom G5 Mobile CGM was attended by hundreds of CGM experts and advocates, representatives from all the major medical organizations mentioned above, as well as many patients and their families.
Many spoke movingly and persuasively on the need for CGM, and how it was already being used non-adjunctively in many cases, as has been shown more than once in Glu’s question of the day. Glu’s Questions of the day, on the topic of using CGMs to correct highs or lows, were used in research for presentations to the FDA. The FDA gave approval for the Dexcom G5 to be used for direct treatment in December 2016, the first and so far only CGM to receive this approval. The decision by CMS followed shortly after. Many of you on Glu helped in this effort to change the CMS policy by writing letters, signing petitions, talking to and educating elected representatives…and finally, we won!
What will CMS Cover when it Comes to CGM?
As of now, the only available CGM device that meets all the CMS criteria for home CGM is the Dexcom G5 Mobile CGM system. CMS will cover home CGM if all of the following criteria are met:
- The beneficiary has diabetes mellitus, and
- They have been using BGM at least 4 times a day, and,
- They are insulin treated and have been using multiple injections of insulin (3 or more per day) or an insulin pump, and,
- The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results, and,
- Within six months prior to ordering the CGM, the treating practitioner has an in-person visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-4) above are met; and,
- Every six (6) months following the initial prescription of the CGM, the treating practitioner has an in-person visit with the beneficiary to assess adherence to their CGM regimen and diabetes treatment plan.
After some delays, Dexcom can now process claims for personal CGM with a Dexcom G5 for Medicare beneficiaries, but the person must sign an agreement that they promise not to access the data on a phone app, or CMS will not cover CGM, and can retrospectively revoke coverage. Yes, you read that correctly.
The rationale offered by CMS is that the receiver is the covered device (now covered under the category of a durable medical good, same as insulin pumps and many other devices), and the sensors and transmitters are disposable supplies for the receiver. To not allow phone use seems to be an unreasonable restriction by CMS, to say the least. Hopefully this can be changed.
Another challenge with the current criteria is that the requirement for 4 BGM checks a day does not distinguish between those who are not currently using CGM, and those that are, and therefore might be doing less than 4 BGM checks per day. Current CGM users might be doing what many CGM users do now: they use well informed and experience based situational judgement on when to trust CGM results, and when to verify. Again, hopefully this requirement can be modified in the future. For now, those wanting CMS CGM coverage need to have an available record of 4 fingersticks a day for at least one month.
Are other CGMs covered?
To require FDA approval for non-adjunctive use means that the Medtronic 670G and earlier Medtronic CGMs are still not covered, despite the fact that the Medtronic pump can act on CGM information without BGM verification, that is, it is used therapeutically. In addition, the only Dexcom version covered is the Dexcom G5, even though the current version of the Dexcom G4 (which has had the 505 programming update for several years) has the same accuracy. The currently available Animas Vibe and T-Slim G4 have an earlier version of the Dexcom G4 CGM, and are thus not covered by CMS either.
Additional Information on CMS CGM Coverage
Dexcom has paired the Dexcom G5 with an Ascencia Contour Next One meter and strips (same as the Bayer Contour Next) in order to get coverage. There are 2 forms that need to be completed, available from Dexcom:
- One that allows an assignment of benefits (AOB form)
- One for you doctor or health care provider to complete (Certificate of Medical Need ).
If you have Medicare as your primary form of insurance and would like to start on CGM, you can contact Dexcom, which has a dedicated line for Medicare patients via their main number (888-738-3646) and you can get more information from their website.
For those who are on Medicare but have had CGM coverage via a secondary insurer, you should check with your secondary insurance on any changes. It is likely that many secondary insurances, usually available via a prior employer or military service, will eventually not provide primary coverage for separate CGM, since Medicare now does.
What will happen to secondary coverage for CGM via Medtronic pumps will also need to be determined, but one would expect that they would still be covered by a secondary insurance, if they were in the past. Again, check with your insurance.
CGM is not right for everyone, but I and many others believe that all T1D patients should have access to it. Someone with T1D should have the choice on whether to take advantage of this potentially life changing technology, and have it be covered, and affordable. Actually, Medicare coverage also applies to those people with type 2 diabetes who are on intensive insulin therapy and use pumps or multiple injections—this represents a big step forward for the broad diabetes community.
Coverage of CGM by CMS followed more than ten years of effort by literally thousands of people, to make CGM available to one of the most vulnerable groups with T1D, those on Medicare through age or disability. Many are long term survivors of T1D. The T1D Exchange helped in this effort. And you helped. Congratulations to the entire T1D community!