No App With That: CMS Exclusion Irks Diabetes Device Users

Miriam E Tucker

September 07, 2017

Medicare's lack of reimbursement for the Dexcom G5's smartphone app is casting a shadow over the long-awaited and much-welcomed January 2017 announcement that the continuous glucose monitoring (CGM) system would be covered for qualifying beneficiaries who use insulin.

Because the app is not "durable medical equipment [DME]," Medicare bars beneficiaries from using it at all, even in conjunction with the CGM system's durable receiver device.

Dexom is working with the Centers for Medicare and Medicaid Services (CMS) to address the issue, but in the meantime, this means that Medicare beneficiaries must carry an extra device around with them and are excluded from the Dexcom's "share" function, which allows another person to remotely monitor the wearer's glucose levels via the app.

Anger and Frustration at Policy

J Daniel Jones, MD, a semiretired radiologist in Orlando, Florida,  with type 1 diabetes who recently aged into Medicare after using the Dexcom G5 for the past 14 months, is angered by the policy.

"It is positive that CGM has been approved for Medicare recipients. However, this is a limited approval excluding total and complete use of the Dexcom device.…I don't think anybody expects Medicare to pay for a smartphone. At issue is the option to be able to use the smartphone and be able to use this feature that we've been using prior to turning age 65 but is now suddenly denied."

The lack of access to the "share" function is particularly egregious, Dr Jones believes, given that seniors are at increased risk for hypoglycemia and hypoglycemia unawareness.

"I think it's absolutely dangerous that a Medicare recipient would be excluded from 'share.'…This is a huge feature that's being denied over bureaucratic terminology, not common sense or what's right for patients. It's just absolute nonsense."

Expressing similar outrage in a recent blog post on the issue, endocrinologist and diabetes technology expert David Ahn, MD, of the University of California, Los Angeles, called the policy "absolutely ridiculous."

Dr Ahn told Medscape Medical News, "I'm not a lawyer or an expert when it comes to defining durable medical equipment, but casually perusing a list of other DME, it appears that wheelchairs and walkers fall in that category. Would they disallow those items if you attach tennis balls to the bottom of the walker to improve grip or add an attachment/brace to the wheelchair? It just seems arbitrary and ill-intentioned to go out of their way to prevent a beneficial-use case for CGM."

Dr Jones also voiced concern about a broader issue — the fact that the policy speaks to Medicare's evident inability to keep up with advances in medical technology.

"This decision, if used for a precedent, would significantly prevent and limit smartphones and apps as adjunct medical devices for personal medical decisions and integrated care, [even as] Apple and the tech world are rapidly advancing this technology to the public good.…I would think that tech industries would be all over and against this ruling, as an affront to their development," he commented.

Indeed, Medicare does not currently cover the "hybrid closed-loop" Medtronic 670G system comprising both an insulin pump and a CGM device and viewed by some as the first "artificial pancreas."

It also doesn't cover the Omnipod insulin delivery device (Insulet), which performs the same functions as do insulin pumps that are covered but doesn't use tubing, so the actual insulin delivery device ("pod") worn on the body is disposable whereas the durable device — the controller — is separate.

However, Medicare may cover the just-approved Tandem Diabetes Care t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM Integration, as evaluated on a case-by-case basis, a Tandem spokesperson told Medscape Medical News.

Defining "DME"

The app issue comes down to the definition of "durable medical equipment."

In January 2017, the CMS announced that Medicare would cover the Dexcom G5 CGM system for eligible beneficiaries. That decision followed the US Food and Drug Administration's December 2016 approval of the G5 for "nonadjunctive" insulin dosing decisions, meaning that it could replace fingerstick blood glucose measurements. In March, CMS spelled out the specifics for coverage.

At the time, the CMS policy stated, "The Medicare DME benefit excludes coverage for nonmedical items, even when the items may be used to serve a medical purpose. As a result, smart devices (smartphones, tablets, personal computers, etc) are not covered by Medicare under this exclusion."

However, what wasn't clear to many then — and has only been clarified recently — is that this policy essentially rules out use of the smartphone app, even though it can be used along with the receiver at no additional cost.

A CMS statement provided to Medscape Medical News explains that the Medicare DME definition requires that "the covered item be durable and withstand repeated use" and also that the DME be "primarily medical in nature and not useful in the absence of illness or injury."  

Of the three components of the Dexcom G5 CGM system, two are disposable: the sensors, which are worn up to 7 days before being discarded, and the transmitters, which last 3 months. The receiver device, about the size of a pack of cards, is the only durable part. The sensors and transmitters can be covered under the benefit only when they are used in conjunction with a durable piece.

Thus, "if the patient is using a smartphone and app [instead of the receiver] with disposable sensors and transmitters, then no part of the system meets the Medicare definition of durable medical equipment," according to the CMS statement.

Dr Ahn isn't buying it.

"Smartphones are not DME. I understand that 100%. I don't want my tax dollars to be buying smartphones for patients. But that doesn't necessitate the next step to invalidate the Dexcom as durable medical equipment if using a smartphone."

Dexcom Working to Change Policy

For its part, Dexcom is doing what it can to comply with the CMS policy while working with the agency to change it, at least with regard to the "share" feature.

"Dexcom has no ability to override this requirement, so we have adapted our technology to ensure strict adherence, because we want to protect our patients' ability to be reimbursed," Dexcom said in a statement to Medscape Medical News.

Since this is a Medicare decision and not Dexcom's, the company is directing beneficiaries to call 1-800-MEDICARE with any questions about the Medicare requirements for Dexcom CGM. Patients may also purchase a Medicare-unreimbursed Dexcom system with a prescription, according to Dexcom.

Meantime, "we realize that many patients want to use their G5 app on their smartphone so that they can share their glucose data with loved ones and caregivers in real time, a feature that is not available using only the receiver....This is a very important safety feature for the Medicare population, and we are continuing to work with CMS regarding this issue."

According to the statement CMS provided, "National coverage determinations [NCDs] are made through an evidence-based process, with opportunities for public participation. In some cases, CMS's own research is supplemented by an outside technology assessment and/or consultation with the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).

"In the absence of a national coverage policy, an item or service may be covered at the discretion of the Medicare contractors based on a local coverage determination (LCD). Information about the process by which coverage determinations are made is available on our website."

Dr Jones and Dr Ahn have no relevant financial relationships.  

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