“Breakthrough” is sometimes an overused word in healthcare. But not this time.

The Food and Drug Administration’s (FDA) Breakthrough Device Designation (BDD) program is an innovative effort to recognize cutting edge medical technologies sooner and get them to patients faster.

“It really is a groundbreaking program,” said Dr. Rick Kuntz, senior vice president and chief medical and scientific officer at Medtronic. “It’s all driven by the recognition that there’s a need to prioritize our resources and efforts to the most significant new device technologies so we can get them to patients more quickly.”

Here’s how it works:

• A company can apply for BDD status, by showing its device “provides for more effective treatment or diagnosis of life-threatening… human disease or conditions.”
• The device must also meet criteria that examines the novelty of the technology. Click here for a full description of the program. 
• If FDA approves the application, device developers receive early and more frequent engagement with regulators throughout development and approval of the technology.

This helps to “make the development and review process more efficient, and to facilitate generation of robust evidence required to support product marketing authorizations,” wrote FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, in a joint statement announcing the program in late 2018.

So far, 13 Medtronic devices have achieved breakthrough status, including four in 2020 alone, despite business disruptions caused by the pandemic.

Policy makers are now considering adding a unique new element to the program that could speed the process even further. “Reimbursement,” Kuntz said. “It’s a critically important factor to consider.”

Under the latest proposal, the Centers for Medicare and Medicaid Services (CMS) would recognize the FDA’s breakthrough designation, and automatically cover the use of breakthrough devices with Medicare patients for a set number of years. The most recent proposal would build on earlier policies from CMS to assure that breakthrough devices are paid adequately when used in the hospital setting. If approved, the new rules would create a virtually unprecedented level of alignment of regulatory and reimbursement steps along the path of patient access to innovative products.

“The fact that FDA and CMS, complex agencies with different missions and separate standards, are coming together like this, has very significant implications,” said Jeff Farkas, vice president of health economics, reimbursement and government affairs for the diabetes business at Medtronic. “Hospitals can be assured that breakthrough devices will be covered and they’ll be paid appropriately for deploying cutting-edge technology, and developers can be encouraged their research and development will be rewarded.”

CMS published the proposed new rule in September and a final decision is expected soon. Medtronic and others in the device industry have long encouraged regulators to consider such an expedited, but still rigorous, process.

Editor’s Update: CMS issued a final rule on January 13 authorizing the expedited review process. Click here to read the CMS release.

“We believe these rules could go a long way toward modernizing payment and coverage of transformational medical technologies, incentivizing innovation, and most importantly, improving patient care by ensuring Medicare beneficiary access to these new therapies,” said Dr. John Liddicoat, executive vice president and president of the Americas region at Medtronic.

Regulators and device companies ultimately share the same goal, Kuntz added. “We all want to help patients and do it as quickly as possible. We can achieve better success at that by working together.”

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