Medtronic’s RDN GM shares reimbursement advice and his ‘airplane moment’

FDA approval isn’t the finish line for a new medical device or innovative system. You’ve got to get paid.

Medtronic won FDA approval for its Symplicity Spyral renal denervation (RDN) system in 2023 after a long journey of starts and setbacks, but the minimally invasive treatment for hypertension achieved another major milestone this year with the start of a a U.S. Centers for Medicare & Medicaid Services national coverage analysis (NCA).

In a recent interview with Medical Design & Outsourcing, Medtronic VP and RDN GM Jason Fontana offered advice from the world’s largest medical device company for other device developers who might one day be looking for their own NCA.

“We’ve been very fortunate — our organization and our team — having experts in reimbursement,” he said.

Fontana started by breaking down the overall process into three pieces or steps.

“The first step is coding. That means that there is a code for your device so you can do the procedure or your device is used and that procedure is captured,” he said. “The second is payment … and there’s two dynamics here: you have in-hospital procedures done within a hospital and outpatient procedures done outside the hospital.”

The third step is that NCA, which offers device developers a definitive timeline of likely coverage through Medicare and which patients will be covered.

“We’ve been working closely with CMS to find that patient population to be covered,” he said. “That’s the third piece of the puzzle.”

Reimbursement advice for device developers

“Make sure you’re thinking not only about the design of the device and the clinical data behind the device demonstrating safety and efficacy, but you should be thinking about that third piece of the puzzle,” Fontana said. “When this device is in an institution, how is it going to be paid for? How do you have that conversation?”

“The good news is when you’re designing the device around clinical efficacy and safety, those are the key things that payers are looking for as well,” he continued. “They want demonstration of efficacy. For renal denervation it’s blood pressure reduction and then does that blood pressure reduction lead to long-term positive impacts — reducing stroke and [myocardial infarction] — and is it safe? So they’re thinking about it from a population dynamic: When you put this device in my population, is the impact going to be positive?”

“The advice I would give to folks that are designing new technology is to think about those three pieces,” he concluded. “Think about making sure you have a safe and effective device, making sure it’s got good short- and long-term clinical data, and then really thinking about how that clinical data impacts a broader population, because that’s going to be your payer dynamic.”

Fontana — who’s been with Medtronic for two decades — says what keeps him going is “the airplane moment.”

“One of the best things about being at Medtronic is I fly a lot. You sit down and somebody asks what you do, you say you work in a medical device company [and] there’s always a story: ‘My brother, my mom, my dad, my friend got a device,'” Fontana said.

“One out of three people in this country have high blood pressure and 75% of them are uncontrolled,” he continued. “There’s a real opportunity to impact change in somebody’s life where it’s dramatically different. Before they even get into the later stages of their life, we’re going to change the trajectory of it in a positive way. My hope one day — and hopefully, as Geoff said, we’re one of these big growth drivers for Medtronic — is I’m on a plane and somebody asks what I do and they say, ‘I got a Symplicity Spyral procedure and my blood pressure’s down.’ That’s the drive behind all of that, which is really exciting.”

More from this interview: Medtronic’s Project Gemini for next-gen renal denervation has a new target