I was surprised, thrilled, elated, stunned, relieved, and every other adjective that you can think of when I received Friday’s mass email from Derek Rapp, JDRF President, with the breaking news:
CMS Labels Continuous Glucose Monitors as Durable Medical Equipment
JDRF is pleased to share that the Centers for Medicare & Medicaid Services (CMS) decided today to recognize continuous glucose monitoring (CGM) devices approved for use in making diabetes treatment decisions as durable medical equipment, a significant step toward making them eligible for coverage under Medicare. Today’s decision lays a pathway toward extension of 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.
In recent years I have wavered between optimism and pessimism as I advocated, hoped, and prayed for Medicare coverage of continuous glucose monitors. Now it looks as though the day is coming! I don’t know how long it will be before procedures are in place for receiving reimbursement, but it will be soon. Soon may mean later in 2017. Soon may mean 2018. But there is finally a path in sight for Medicare reimbursement of CGM’s.
Today I read through the 15-page CMS Ruling with a yellow highlighter. You will find some of the specifics of the report well-described in Mike Hoskins’ Diabetes Mine article: “NEWSFLASH: Medicare Will Cover Some CGMs Now!” Below I will expound on a couple of Mike’s points and then talk more about the specifics of durable medical equipment.
Dexcom Only: This ruling only applies to the Dexcom G5 because it is the only CGM approved by the FDA for insulin dosing. Therefore the G5 is the only system that fits the definition of a “therapeutic CGM.” Currently CGM systems by Medtronic have not been approved for insulin dosing and are considered “non-therapeutic.” They do not fit the definition of Durable Medical Equipment (DME).
No Guarantee of Coverage: This ruling only states that therapeutic CGM systems fall within the scope of Medicare Part B DME. There has not yet been a national coverage determination to guarantee approval if one satisfies still-to-be-determined coverage criteria. Right now MAC’s (Medicare Administrative Contractors) have the option of issuing local CGM coverage determinations or coverage may be obtained on a claim-by-claim basis. What does this mean? We will learn as Medicare beneficiaries begin filing claims for CGM coverage. You can bet that I will apply for coverage as soon as possible after starting Medicare in April.
All Types of Diabetes: Just as people with all types of diabetes are able to receive coverage for home BG monitoring, all PWD will be eligible for CGMs according to this ruling. Don’t get too excited because IMO the coverage criteria will most likely restrict reimbursement to some people with Type 1 diabetes and some insulin-using Type 2’s. Just as it is more difficult for Type 2’s to obtain coverage for insulin pumps, it may be more difficult for them to obtain CGM coverage. But this is still an improvement over the 2015 congressional bills (S.804 and H.R.1427) that specified Type 1 diabetes.
One thing not addressed in Mike’s article is how the Dexcom G5 fits into the Medicare definition of Durable Medical Equipment (DME).
According to the CMS ruling, there are 5 criteria which must be established in order for a device to considered as DME:
- Can withstand repeated use;
- Effective with respect to items classified as DME after January 1, 2012, has an expected life of at least 3 years;
- Is primarily and customarily used to serve a medical purpose;
- Generally is not useful to a person in the absence of an illness or injury; and
- Is appropriate for use in the home.
Home blood glucose meters and supplies have been in this category for a long time. Technically the meters are “durable” and have an expected life of at least 3 years. For “multicomponent” systems, the other components are covered as long as one component (the meter) is “durable.” Therefore test strips are covered because they are an integral part of the system.
Looking at the Dexcom G5 system, CMS quickly specifies that sensors with an expected life of 1 week are not durable. Neither are transmitters with an expected life of 3 months. So we are left with the receiver. According to CMS, “reliability analysis data from an engineering firm that evaluated the receiver component of the recently approved therapeutic CGM predicts a lifetime of greater than 3 years for the receiver.” CMS goes on to say that the receiver “is the only component of the therapeutic CGM that can be considered durable and satisfy the 3-year MLR criterion of the definition.”
What does this mean? It means Love Your Receiver!!! Without the receiver, the Dexcom G5 system does not satisfy the criteria for DME.
The FDA approval of the G5 system required the purchase of a receiver and many people complain about that requirement since they use their phones as the receiver. Just know that CMS is never going to classify your phone as a reimbursable medical device, so cherish your receiver even if you never take it out of the box. If you’re not on Medicare, still cherish your receiver so that seniors can receive CGM coverage! Also Medicare coverage of CGM’s is important for everyone because it is a vital component to coverage of artificial pancreas systems.
In the coming weeks and months, we will learn more about the implementation and impact of this CMS ruling. If you’d like to learn more, here are a few links.
Diatribe’s Preliminary Analysis
And no matter what, don’t forget to Love Your Receiver!
Test Guess and Go 