The Reimbursement Story

Navid Khodaparast [00:00:05]:
Dan, you get a lot of questions. FDA was probably one. Patents, clinical trials. What's the biggest question that you get now?

Daniel Powell [00:00:16]:
“Is this reimbursed?” That’s the biggest question and the biggest challenge in bringing a novel medical device to market—it’s new. And the government body that oversees reimbursement is CMS.

Navid Khodaparast [00:00:32]:
The one that has two M's but only one.

Daniel Powell [00:00:34]:
The Centers for Medicare and Medicaid Services. Yeah, but one M. They’re in charge. It’s a whole process to get reimbursed. So, that’s the number one thing we’re focused on now. First, you run a clinical trial, get FDA approval—

Alejandro Covalin [00:00:55]:
Be published.

Daniel Powell [00:00:56]:
Be published in that clinical trial.

Navid Khodaparast [00:00:58]:
Certain level of evidence.

Daniel Powell [00:01:01]:
Then figure out your category. A wearable neurostimulator is new. Only a couple of us on the market—tremor, restless leg syndrome, addiction management. We’ve now agreed with CMS on the category: durable medical equipment.

Daniel Powell [00:01:18]:
Normally, that’s wheelchairs and crutches. They’ve shoehorned our device into this category. This made engineering mission-critical, because durable medical equipment requires a three-year lifespan. That’s a legal definition.

Daniel Powell [00:01:38]:
So walk us through that.

Alejandro Covalin [00:01:58]:
The best way is to use it for three years, but that takes too long. So, we do accelerated aging tests—under specific conditions, each hour simulates many hours of aging. It must be done in an accredited lab, with strict calculations to show equivalency to a three-year lifespan.

Daniel Powell [00:02:48]:
The good news: we succeeded. We were granted durable medical equipment status. We submitted testing documentation and got a unique billing code—called a HCPCS code. But what we don’t yet have is a payment determination. No coverage amount yet. That’s part of the journey.

Navid Khodaparast [00:03:25]:
So we have coding, but no coverage or payment. How do we get the last two?

Daniel Powell [00:03:34]:
Great question. Now we seek coverage and payment amounts. CMS covers Medicare—that’s people 65+. That’s about 6% of the addiction population. Not our core group.

Daniel Powell [00:03:55]:
Then you have 50 states with Medicaid. And managed Medicaid—run by third parties or by the state. Sometimes both. For example, Philadelphia has its own Medicaid program separate from Pennsylvania’s.

Daniel Powell [00:04:12]:
Medicaid covers people least able to pay—but who need this product the most. So we’re working with states, trying to meet with health and human services directors. Then there’s private insurance—hundreds of companies. Even Blue Cross Blue Shield isn’t just one entity—it’s made of seven major groups covering different states.

Daniel Powell [00:04:50]:
We have to get policy decisions at each one. So, we’re starting small—planting beachheads. We’ll begin listing which states have opened up access on our website. This journey takes years—and we’re still early in it. Clinical evidence will also help, which you’re working on.

Daniel Powell [00:05:19]:
Tell us about the studies coming up and what we’re hoping to show.

Navid Khodaparast [00:05:24]:
We need more evidence, always. We have the RESTORE trial, ongoing for over three years. We’re enrolling patients in detox, analyzing how the device helps with acute withdrawal.

Navid Khodaparast [00:05:40]:
But we’re also tracking cravings, treatment retention, and outpatient use—how the device helps post-acute withdrawal, reduces relapse, and manages anxiety, depression, PTSD. All these factors contribute to long-term recovery.

Navid Khodaparast [00:06:24]:
Once we finish analysis, we’ll publish the data and submit it to CMS and private insurers to show how the device is used and its outcomes.

Daniel Powell [00:06:47]:
You’re running the single largest neurostimulation-for-addiction study ever.

Navid Khodaparast [00:06:55]:
Yeah.

Daniel Powell [00:06:55]:
We lead with science and go bold.

Navid Khodaparast [00:06:58]:
We’re pioneering.

Daniel Powell [00:07:00]:
It’s tough because we want to get this in people’s hands. We do have a cash price option, but that’s not ideal. Our mission is to make it accessible for everyone. But reimbursement in the U.S. is complex.

Daniel Powell [00:07:18]:
Still, we’re focused. We know how important it is. “Is this reimbursed?” is the most-clicked question on our website. It’s the question we’re asked most. And it’s our top priority.

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