Longtime type 1 Dan Patrick in Ohio is one of many people with diabetes currently in limbo, waiting for finalization of Medicare coverage of the Dexcom G5 continuous glucose monitor -- facing the uncertainly of not being able to access needed supplies for the CGM he's been using for years.
He's stuck in regulatory purgatory, so to speak -- standing by while Medicare gradually rolls out a CGM coverage policy, painfully slowly and currently lacking clarity for those who need answers ASAP.
"No one knows what to do right now, and that's unfortunate," Dan says. "We're all being left fending for ourselves while the bureaucrats work out the details."
Dan is of course just one of scores of patients on Medicare or close to turning 65 who are facing the same concerns.
While CMS's decision to cover this life-changing technology is of course a positive development that many have been advocating on for years, the practicalities of implementing it are less desirable. Yep, all those jokes about "MediScare" have turned into a reality that many don't know how to navigate.
For those not hip to what's going on, here's the skinny (fraught with acronyms):
Medicare hasn't traditionally covered continuous glucose monitors (CGMs), but limited case-by-case rulings by Administrative Law Judges have allowed some Medicare-covered PWDs (people with diabetes) to get access through the years. In recent years, the Centers for Medicare and Medicaid Services (CMS) has pretty much said they wouldn't cover CGM unless it was determined to be a medically necessary tool, not an "adjunctive" device that supplemented fingerstick BG (blood glucose) tests.
That changed at the end of 2016, when the FDA granted Dexcom G5 a "dosing claim" allowing this most-accurate system to be used instead of fingersticks to make insulin dosing and other treatment decisions. Then on Jan. 12, 2017, the CMS followed in the FDA's footsteps and issued a local ruling (CMS-1682-R) allowing the Dexcom G5 to be covered under Medicare.
As of now, the Medicare CGM coverage ruling only applies to Dexcom's G5, and does not include the competing Medtronic Minimed CGM on the market due to lower accuracy results -- though Medtronic tells us they plan to pursue a dosing claim with the FDA at some point in the future.
When the Dexcom decision came down, many celebrated, but it was in fact still only allowing for limited case-by-case coverage; it did note yet set out a policy for national coverage, or any details on how that coverage would be implemented. Over the past few months, some Medicare vendors have crafted policies on how that might work, and new billing codes for this "therapeutic" designation were even developed in May, but so far CMS has not proposed a national coverage policy.
As a result, many PWDs on Medicare who previously had coverage or are trying to get CGM coverage are being told they can't get the devices and supplies they need because "nothing is finalized yet."
Halting Dexcom Shipments
Dexcom has had to tell its customers on Medicare they can't ship supplies to those individuals, and at the end of May distributor Liberty Medical stopped supplying Dexcom CGM supplies to all those on Medicare due to the widespread confusion.
Dexcom representatives say the company is in constant communication with Medicare about this issue and is working with the federal agency to clarify and adopt a policy that can be implemented nationally.
"It's frustrating for both us and the patients that we can't get our product out the door to those (on Medicare) who need it," said Matt Dolan, Dexcom's VP of corporate development. "We are working on that now, but the practical implementation doesn't happen overnight. We are not sitting idly by, but are working as hard as we can to get all of this finalized."
Dolan says that as exasperating as this all is, the D-Community must keep in mind that this Medicare CGM coverage process is happening more quickly than anyone would have guessed. Originally, no one expected a Medicare decision on CGM coverage until late 2017 or even early 2018.
Perhaps it would’ve been better for Medicare to wait to issue this coverage decision in until they’d had time to better craft practical policies for rolling it out...? Instead, this scattered process is creating some chaos.
And guess who's stuck in the middle? Patients, of course.
Stuck in the Middle
Laddie Lindahl in Minnesota is one of those PWDs effected. A longtime type 1 who blogs over at Test Guess and Go, Laddie has been on Medicare for just a short time in 2017 and is already feeling the effects of this confusing CGM coverage issue (she's written about that here).
So far, she's still been able to get her Dexcom CGM supplies, but she's worried about that going forward, and also believes Dexcom has done a poor job of communicating with customers; she's heard that many were being given different answers.
"So far everything I know about this is a mess," she told us. "It will take time to get worked out. The original list of requirements to receive CGM coverage were so broad that almost everyone who uses insulin would qualify. I expect the next list of requirements to be much more strict."
Another PWD caught up in this is our D-blogging friend Joanne Milo in California who writes at The Savvy Diabetic and has shed some light on a new ruling on this Medicare CGM coverage issue recently.
"The new article indicates that if Medicare beneficiaries use their Dexcom G5 with a smart phone, even if such use is in addition to using the receiver that comes with the Dexcom G5 system, all the CGM supplies will be non-covered," she writes. "...This novel restriction appears to be designed to ensure that the only CGM that is covered by Medicare will not be covered for those individuals who use it to its full functionality to monitor their glucose levels."
Dexcom's Dolan counters this concern, saying the intent is clearly not to limit patient use of smart phones -- but as of now, that's how the policy is worded and can be interpreted. We can only wait and see how Medicare folk handle this moving forward.
Our aforementioned friend Dan Patrick says: “I hate to sound like a conspiracy theorist, but I’m of the opinion that Medicare just doesn’t want to cover CGMs and is trying to railroad us. It was not well thought-out. Medicare is too opaque… Was there any discussion on rolling this out? Did our Diabetes Community get a chance to weigh in before this local coverage determination was decided? The answer is no. We’re dealing with bureaucrats who want to tell us what we can use per day. They didn’t think about what it would take to implement this rule.”
Dan's been on Medicare for three years now, and almost from the beginning has been continuously fighting to get his CGM supplies covered. He started on a Medicare Advantage plan in May 2014 with Humana, and they originally covered the G4 sensors but then everything "blew up" for him.
His first appeal process took 14 months, to get Dexcom G4 supplies such as sensors. He went through three appeals levels, which requires a wait time of 60 days between each to allow for either side to file a counter-appeal to the next level. At the time Humana didn’t appeal up, so he won, and everything was covered for 2014 and 2015.
But then in 2016, a third-party distributor started using the wrong billing code, so Medicare wouldn’t cover Dan’s CGM sensors. That required another round of appeals, just for the CGM sensors alone (not counting the test strip and insulin pump appeals he also had going separately, as well as his need for a new G4 transmitter that required another distinct appeal).
Dan says it took from March to August for CMS to decide to cover his Dexcom sensors in 2016, but instead of covering two years as the doctor’s office prescribed, the Advantage plan changed the Rx to run for just one year so that it expired on Dec. 31, 2016.
Now Dan needed a new prescription and Medicare coverage for 2017 – but that became impossible in January when CMS issued its local coverage decision relating to the Dexcom G5 model only coverage – the billing codes would be changed so that older G4 supplies would no longer qualify.
“This new Medicare ruling has blown all the prior appeals out the window,” he says. “We’re starting at ground zero, like those never happened. That’s disgusting.”
Dan is still waiting for his doctors to get the new G5-specific billing codes -- as the CMS ruling on those new codes wasn't released until March 23, and many still don’t know how these Medicare CGM puzzle pieces fit together to allow for national coverage. He's preparing to file a new appeal.
He also has a concern over Medicare’s ignorance of FDA specs for Dexcom sensors, in that they're approved for 7-day use. While first part of the Medicare ruling on CGM coverage points to this “6-7 day” timeline for safety reasons, the agency only covers one box per month, or 52 sensors per year – meaning you’d be short a full box every year if you follow the 7-day wear.
“(They) basically just overruled FDA safety rulings, and that's a documented safety issue!”
To date, Dan hasn't lost an appeal but with the newest Medicare rulings and no national coverage decision, he believes it's only a matter of time. He's been writing about this situation over on his blog, A Slice of Life with Diabetes.
The Time is Now...
Insurance companies send out their contracts to medical supply distributors during the summer months, leading up to open enrollment periods that typically start in the Fall months. So right now is a critical time. Contracts are being crafted and finalized, and with all this Medicare CGM confusion, insurers and third-party distributors may very well simply leave out any language about Dexcom G5 coverage.
Effectively, Medicare CGM’ers could face no coverage for their Dexcom supplies for 2018 because so much is up in the air right now.
Dan has been following the private Joslin 50-Year Medalist group on Facebook, which includes many older PWDs, and says many are worried about what's ahead. But sadly, too many probably don't realize the real roadblocks they face once they reach Medicare age.
"Someone out there has something I need and can't live without, but you look at all the hassles people must go through," he says. "Why are we building all of these mazes that cost money and cut off access? The only choice we have is to fight."