Dan Arias: Okay, that’s helpful. And then maybe just a follow-up on that topic of reimbursement. If I remember correctly from the call a couple of weeks ago, I think the application for an LCD had been submitted and accepted. Do you think that a draft coverage policy could show up in a similar timeframe as the FDA approval, which I know you mentioned is an uncertainty in itself, but just from a timing perspective, does it look like meetings and conversations that you’ll have with CMS are tracking towards first quarter or second quarter of the calendar year at that timeframe? Thanks.
James McCullough: Yes. So, I’ll let Tom answer that, and timing is always difficult. But with that caveat, it looks like when it rains, it’s going to pour. So, we may see a confluence of events here going into the next calendar year, but Tom, why don’t you answer specifically?
Thomas McLain: Sure. Thanks, James. The contractor that we’re working with Dan has quarterly open meetings, so it is possible that there could be a coverage determination for consideration at either of those meetings.
Dan Arias: Okay, terrific. Thank you, Tom.
James McCullough: Thank you, Dan.
Operator: Thank you. One moment for our next question. And that will come from the line of Mark Massaro with BTIG. Please go ahead.
Mark Massaro: Hey guys. Thank you for the questions. I think going through my notes and just remembering the last call, I believe the majority of your volumes came from Mount Sinai. I guess can you just maybe provide us with an update of what procedures you have in front of you with the VA just to try to increase volumes across the VA hospitals. I recognize that working with the VA can be challenging given that I think you have to go hospital to hospital, but can you just give us an update there? And to what extent do you think the VA can start to really build relative to your overall volume mix?
James McCullough: Yes, it’s a very good question and the VA remains a very important opportunity, especially because we have secured coverage through the 10-year government contract, and it is taking longer because the VA is very complicated as you point out, but I think it would be helpful, Tom, if you could answer from an operations standpoint and also from a technology standpoint for some of the opportunities coming up in the VA focus if you could chime in after, Tom?
Thomas McLain: Sure. Thanks, James. So Mark, VA is a significant opportunity for us. There is a large population that would benefit from KidneyIntelX testing. On the traditional approach with the VA, which is to secure contracts like laboratory services agreement and contracted purchase agreements. We are making the initial gains there by entering into those agreements, but with the super majority insurance coverage that James has spoken about, it’s giving us the opportunity to have those government account execs now also call on physicians in the community. And that is an important opportunity with coverage and payment like James has described, but it also opens up the opportunity to provide KidneyIntelX testing for veterans who are receiving care in community practice offices.
That’s allowing us to drive volume in VA centers that will be important evidence of utilization for securing expanded laboratory service agreements and purchase contracts. So, it’s very synergistic with what we’re doing to develop that direct to primary care practice model and that’s becoming an important driver for that part of the business, the VA side of the business as well. On the technology front, Fergus?
Fergus Fleming: Yes. I mean, as we scale within the VA and grow those volumes and grow those relationships with individual VA facilities, one of the key drivers is ensuring that we can deliver this solution in the seamless frictionless way to the provider, while at the same time being very cognizant and adhering to the strict data protection and privacy framework that applies within the VA. To address those challenges, we have been very fortunate to work with at a national level with the VA on an solution whereby we’re working on deploying our KidneyIntelX solution within the VA’s own cloud infrastructure so that we can provide the same level of ease of use test supplies to other health systems to all our organizations within the VA by allowing them to order the test and receive the reports within their own IT infrastructure, without the need for us to extract their data and be subject to the very strict regulatory framework that would therefore apply.
So, we’ve got some significant milestones in recent weeks in relation to that program. We’re now moving into a new phase of implementation whereby we will begin to deploy our code into the VA’s own cloud infrastructure, which they call the enterprise cloud and we’ll be one of the first companies to partake in that type of the endeavor. So, that’s happening in parallel. as volumes grow, as they are as the cadence become into place, the ability to be able to deliver that service to that seamless order and reporting infrastructure will be pivotal.
Mark Massaro: Okay, great. It’s nice to see that you’re getting paid through the ICR process for Medicare. Would it be possible for you to clarify, are you getting paid on the majority of the claims that you’re submitting to them or are you getting paid on all of them? Just any sense for how the ICR process is going?
James McCullough: Tom, do you want to respond to that?
