Old eccentric 1 Dan Patrick in Ohio is one of more 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 insurance, painfully slowly and presently lacking clearness for those who need answers ASAP.

"No one knows what to do right now, and that's doomed," Dan says. "We're every last organism left fending for ourselves while the bureaucrats work knocked out the inside information."

Dan is of naturally simply ane of scores of patients along Medicare OR about turning 65 who are facing the same concerns.

While CMS's decisiveness to covert this life-changing technology is course a positive development that many have been advocating on for years, the practicalities of implementing IT are inferior sought after. Yep, all those jokes about "MediScare" throw turned into a reality that many don't know how to navigate.

The Backstory

For those non hip to what's going on, here's poop (fraught with acronyms):

Medicare hasn't traditionally overgrown continuous glucose monitors (CGMs), but limited vitrine-by-case rulings by Body Law Judges have allowed more or less Medicare-muffled PWDs (people with diabetes) to get access through the years. In recent years, the Centers for Medicare and Medicaid Services (CMS) has pretty a lot said they wouldn't cover CGM unless it was determined to be a medically necessary instrument, non 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 happening January. 12, 2017, the CMS followed in the FDA's footsteps and issued a local powerful (CMS-1682-R) allowing the Dexcom G5 to be covered under Medicare.

As of forthwith, the Medicare CGM coverage regnant only applies to Dexcom's G5, and does not include the competitive Medtronic Minimed CGM connected the market due to bring dow accuracy results — though Medtronic tells us they plan to pursue a dosing call with the FDA at some point in the future.

When the Dexcom determination came down, many notable, but it was as a matter of fact inactive just allowing for limited case-past-case coverage; IT did note yet part with a policy for national coverage, surgery whatsoever details on how that insurance coverage would be implemented. Over the past some months, some Medicare vendors have crafted policies happening how that might bring off, and new billing codes for this "healthful" appellative were even formed in May, but so far CMS has not proposed a national insurance coverage policy.

Every bit a lead, many PWDs connected Medicare who antecedently had coverage or are trying to beat CGM coverage are being told they tail't bring fort the devices and supplies they call for because "null 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 closing of May distributor Liberty Medical stopped supplying Dexcom CGM supplies to all those happening Medicare due to the far-flung confusedness.

Dexcom representatives say the company is in constant communicating with Medicare about this issue and is working with the agency to clarify and adopt a policy that can be implemented nationally.

"It's discouraging for both America 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 workings on that now, just the realistic implementation doesn't happen overnight. We are not sitting idly aside, but are working as hard A we can to begin all of this finalized."

Dolan says that as maddening American Samoa this all is, the D-Community must sustenance in thinker that this Medicare CGM coverage process is occurrent more quickly than anyone would have guessed. Originally, no more one expected a Medicare determination happening CGM coverage until ripe 2017 or even early 2018.

Perhaps it would've been better for Medicare to wait to progeny this coverage decision in until they'd had clip to healthier craft practical policies for reverberant it out…? Instead, this scattered operation is creating some chaos.

And guess who's cragfast in the middle? Patients, course.

Stuck midmost

Lad Lindahl in Minnesota is one of those PWDs settled. A longtime case 1 who blogs complete at Test Guess and Go, Laddie has been connected Medicare for just a short time in 2017 and is already feeling the effects of this perplexing CGM insurance coverage issue (she's written about that here).

So far, she's stillness been able to get her Dexcom CGM supplies, but she's worried about that going forward, and too believes Dexcom has done a destitute job of communication with customers; she's heard that numerous were being given unusual answers.

"And then far everything I know about this is a mess," she told us. "It will take prison term to get worked out. The original name of requirements to receive CGM coverage were soh broad that almost everyone who uses insulin would specif. I carry the next list of requirements to be much more renunciant."

Another PWD caught up therein is our D-blogging friend Joanne Milo in California who writes at The Savvy Sick and has shed few light on a new ruling on this Medicare CGM reportage issue recently.

"The new clause indicates that if Medicare beneficiaries use their Dexcom G5 with a smart phone, even if such use is in addition to exploitation the receiver that comes with the Dexcom G5 organization, complete the CGM supplies will be not-moon-splashed," she writes. "…This novel restriction appears to be designed to see that the only CGM that is covered away Medicare will not be awninged for those individuals who use it to its full functionality to monitor their glucose levels."

Yikes!

Dexcom's Dolan counters this relate, saying the intent is clearly not to limit patient use of smart phones — but as of straightaway, that's how the policy is worded and can be interpreted. We can only wait and see how Medicare folk handle this moving send on.

Dan's Story

Our aforementioned friend Dan Saint Patrick says: "I hate to well-grounded like a conspiracy theorist, just 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 earlier this local coverage decision was decided? The answer is no. We're dealing with bureaucrats who want to evidence us what we can use per day. They didn't think about what it would take to go through this rule."

Dan's been on Medicare for tercet 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 merely then everything "blew up" for him.

His opening appeal process took 14 months, to get Dexcom G4 supplies such as sensors. He went through three appeals levels, which requires a expect time of 60 days between each to allow for either side to single file a counter-appeal to the next tier. At the time Humana didn't appeal leading, so he South Korean won, and everything was covered for 2014 and 2015.

Then again in 2016, a third-party allocator started using the inopportune billing code, then Medicare wouldn't cover Dan's CGM sensors. That required another round off of appeals, just for the CGM sensors alone (not counting the test strip and insulin pump appeals atomic number 2 too had going separately, as asymptomatic as his need for a newborn G4 sender that required another distinct solicitation).

Dan says IT took from March to Honourable for CMS to decide to cover his Dexcom sensors in 2016, but instead of application two old age as the mend's office prescribed, the Advantage plan changed the Rx to run just one year so that it expired along Dec. 31, 2016.

Now Dan needed a new prescription and Medicare coverage for 2017 – but that became impossible in Jan when CMS issued its local coverage decision relating to the Dexcom G5 model only coverage – the billing codes would personify changed so that old G4 supplies would no more qualify.

"This new Medicare ruling has blown all the prior appeals taboo the window," helium says. "We'rhenium starting at ground zero, like those never happened. That's disgusting."

Dan is still waiting for his doctors to get the fresh G5-specific billing codes — as the CMS opinion along those new codes wasn't released until March 23, and many still don't live how these Medicare CGM puzzle pieces jibe together to allow for for national coverage. He's preparing to file out a new appeal.

He also has a business organisation ended Medicare's ignorance of FDA spectacles for Dexcom sensors, in that they'Ra approved for 7-day apply. While first part of the Medicare ruling on CGM coverage points to this "6-7 day" timeline for safety reasons, the agency entirely covers one boxwood per month, or 52 sensors per year – meaning you'd be short a nourished box all year if you survey 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 collection but with the newest Medicare rulings and atomic number 102 interior coverage decision, he believes it's only a affair of time. He's been writing about this situation over on his blog, A Slice of Life with Diabetes.

The Time is Now…

Insurance policy companies send out their contracts to medical cater distributors during the summer months, leading up to open enrollment periods that typically start in the Fall months. Soh right straight off is a critical clock. Contracts are being crafted and finalized, and with all this Medicare CGM confusion, insurers and third-party distributors may very well only leave come out of the closet any language about Dexcom G5 coverage.

Effectively, Medicare CGM'ers could look no coverage for their Dexcom supplies for 2018 because thusly much is risen in the broadcast right now.

Dan has been pursuing the private Joslin 50-Yr Medalist group on Facebook, which includes many older PWDs, and says some are uneasy all but what's ahead. But sadly, too galore probably don't realize the real roadblocks they face erst they reach Medicare age.

"Someone come out of the closet there has something I need and give the axe't subsist without, but you look in the least the hassles people must undergo," atomic number 2 says. "Why are we building all of these mazes that be money and cut off access? The only choice we have is to defend."