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Medical devices need government, insurance support

Medical devices ranging from mobile healthcare apps and accessories to pacemakers and stents offer the potential to extend life and decrease costs. Senior technical editor Tom Lecklider took a look at mobile apps in our April issue while medical devices of all types were the focus of the BIOMEDevice show held March 26 and 27 in Boston.

Speaking March 27 at BIOMEDevice, Bill Betten, vice president of business solutions at Logic PD, cited benefits of mobile healthcare. By 2020, 55 million Americans will be over 65. A day in the intensive care unit can cost $10,000, he said, while the expense of a mobile healthcare app might be $1 per day. We must, he said, push to shift care from ICUs to assisted living facilities and the home.

Unfortunately, researchers at the Brookings Institution have concluded that policy makers are not adequately promoting mobile healthcare technology, as detailed March 12 by Clara Ritger in the National Journal.

Ritger reported two key roadblocks: physicians don’t get reimbursed for using mobile technology to deliver healthcare, and developers hesitate to innovate because they are unclear on the rules and regulations mobile apps might need to meet.

She quoted Darrell West, founding director of the Center for Technology Innovation at Brookings, as saying, “There’s a chicken-and-an-egg problem”—the Centers for Medicare and Medicaid Services in the United States, for example, doesn’t want to provide reimbursements until mobile apps’ benefits have been demonstrated, but mobile apps won’t be widely deployed unless there are reimbursements.

Government-related issues extending beyond mobile healthcare were the focus of another BIOMEDevice speaker—Thomas J. Sommer, president of the Massachusetts Medical Device Industry Council (MassMEDIC), which serves about 330 medical device makers in Massachusetts and nearby states.

In a presentation titled “Public policy’s impact on the medtech sector,” Sommer cited the 2.3% medical device excise tax as a drag on the industry. This tax, it should be noted, generally does not apply to retail purchases of items intended for personal use.

The tax issue is contentious. Some say that by subsidizing insurance for the currently uninsured, the tax will drive up demand for medical devices. Others contend that most patients needing devices like stents and pacemakers, by virtue of being over 65, already are insured by Medicare.

In addition, Sommer noted that budget sequesters have hindered the FDA approval process, although FDA hiring and training have recently resumed. He also cited the end of the fee-for-service era, which will bring about an environment in which new technologies do not fare well.

Apart from tax and approval issues, early research indicates the benefits of mobile health technology. Ritger in the National Journal quoted West at Brookings as saying, “What people are finding is that patients pay closer attention to their health when they’re wearing a device knowing that their vital signs are going directly to their doctor. You get a preventive health benefit, and doctors get real-time data to make proactive decisions about treatment.”

Many sufferers of chronic disease could benefit. According to 2013 figures from the American Diabetes Association, 215,000 Americans under 20 have diabetes, as do 14.7 million Americans between 20 and 65 and 10.9 million over 65—all of whose quality of life could be improved through the use of cost-effective home glucose monitors and insulin pumps.

With the money- and life-saving benefits of the devices, it is clear that governments and insurance companies should be working to widely deploy the technology without unduly burdensome tax, approval, and reimbursement policies.

Rick Nelson
Executive Editor
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