Medicare patients with insulin-dependent diabetes will soon be able to share information from their approved continuous glucose monitor (CGM) with designated caregivers and health professionals using smart phone apps, according to a new statement from the Centers for Medicare & Medicaid Services (CMS).
On Monday, June 18th (2018), CMS will post information to their website to alert people that beneficiaries can use smartphones etc. “in conjunction” with the durable receiver.
The new ruling, which impacts everyone on intensive insulin therapy of Medicare age, will impact about 600,000 people, according to a representative from Dexcom, a maker of mobile CGM apps.
The rule change follows a push from lawmakers, diabetes advocates, and stakeholders, who have called for coverage of connected smartphone apps since CMS first announced certain CGM devices would be covered in January 2017.
Initially, only Medicare beneficiaries will be covered, but private insurers often follow Medicare’s lead, opening the field to possible expanded coverage in the near future.
CGMs are items of durable medical equipment that provide critical information on blood glucose levels to help patients with diabetes manage their disease. Past rulings from Medicare limited the use of CGMs in conjunction with smartphones, preventing patients from sharing vital data with family members physicians and caregivers.
CGMs currently approved by CMS include the Dexcom G5, the recently-launched Dexcom G6, and the Freestyle Abbott Libre, but the Libre’s smartphone app has yet to be approved by the FDA. Therefore, the ruling will mainly impact Dexcom users.
Current and eligible Medicare patients can download the Dexcom G5 Mobile app to compatible iOs and Android devices via iTunes and Google Play and log into their Dexacom account, according to the company. The Dexcom G5 is compatible with iPhone X, 8,7 and 6, in addition to 14 of the top 30 Android phones. It also works with the Apple Watch and Android Wear Watches. Visit Dexcom's website for a current list of compatible devices.
Smartphone connections were initially banned since the federal agency followed a strict definition of what’s classified as Durable Medical Equipment (DME) and saw the handheld CGM receiver as an essential part of the system. Using the CGM with the smartphone app—rather than the receiver—negated their coverage policy.
Patients were initially penalized if connected mobile apps (rather than receivers) were used with covered CGMs. There was also concern that patients might expect coverage for smartphones if mobile apps were permitted.
Because the smartphone apps allow patients to share information with providers and caregivers were forbidden to be used, many patients have been “left scratching their heads over why they didn’t do this sooner,” says Joanne Rinker, MS, RD, CDE, LDN, FAADE, director of practice and content development for the American Association of Diabetes Educators.
Rinker says she is “thrilled” with the decision.
“The smartphone apps provide a number of benefits to patients, particularly children and the elderly, who may have long-distance caregivers. With the apps, caregivers can better monitor their patients’ diabetes,” says Rinker. It will also allow healthcare providers to interpret data from meals, exercises, medications, insulin boluses and more to make improved treatment decisions.
A statement issued by CMS Durable Medical Equipment Center notes that the new changes “are consistent with the Agency’s approach of putting patients first and incentivizing innovation in the use of e-technology.” The modified policy will “support the use of CGM’s in conjunction with a smartphone, including the important data sharing function they provide for patients and their families.”
The use of smartphone apps will allow clinicians to review a patient’s results and sometimes, if needed, be able to make real-time recommendations, says Rinker.
“For someone like a child, who is at school, the app is going to deliver information about the results to someone who has been approved to share with that person,” says Rinker.
“The biggest thing is that parents and caregivers of elderly adults can rest easy and that it’s great for clinicians for tracking and monitoring patients and making real-time recommendations, perhaps for a patient who may be trying a medication they’ve never been on before,” says Rinker. “For people who may be on one-person support teams, the app really gives them all the information that they need to be able to help them be more successful.”
“I would imagine that private insurance will follow suit, and I would hope they would do it quickly,” she says.
CMS Administrator Seema Verma tweeted that fixing this issue puts patients in control. And that “if you use a CGM and are used to getting information on your phone and not just on a receiver, CMS will no longer stand in your way.”