CareDx, Inc (NASDAQ:CDNA) Q4 2023 Earnings Call Transcript

That’s something where we have our KAOR study that can help generate data that may, in fact, be impactful evidence that can help bring back some of the coverage. So I think there’s a number of shots on goal here for us to continue on growing it and making sure that coverage model evolves from where it is today.

Alex Nowak: Can you just outline the scenarios here with the LCD, if it does get finalized as it stands at Medicare, I guess, what could happen?

Alexander Johnson: Just to clarify. Sure. Maybe I’ll ask Robert to answer this. But I think just to clarify your question, meaning what would change with our business if it was solidified today as what’s the — maybe you can clarify the question a bit?

Alex Nowak: Absolutely. Scenarios on when this LCD does get finalized because, again, Medicare came out with a draft and ideally that, I guess, legally, they have to finalize that within a year if they’re going to do so. So when it does get finalized, is that going to change, whether it be transplant centers interpretation of what they can get bills for or what you can get bills for and thus, what test they can run? I’m just trying to understand how this changes the scenarios out there.

Robert Woodward: This is Robert. So the draft thinking about with very closely parallels and incorporates a lot of the language from the billing articles. And so it really seems to have been their response to a lot of pressure that there wasn’t a public process, so they put in place a public process to get to the same place, even though they didn’t help what they had already done. So as already been mentioned, our base case for the business is that it’s going to be this way and as is in the billing article. And if finalized in their draft form if they didn’t make any changes or any substantive changes, then it would continue as currently for patients and businesses and providers, as far as finding ways to do the testing within the scope of what they’re allowing.

Alex Nowak: Got it. Makes sense. Lastly, just any status on the DOJ inquiry.

Abhishek Jain: No, nothing material over there, Alex. We have disclosed in the 10-K, whatever we had to, but on the DOJ side, nothing of substance.

Alex Nowak: All right. Appreciate the update. Thank you.

Operator: Our next question comes from Yi Chen with H.C. Wainwright. Please proceed with your question.

Yi Chen: Thank you for taking my questions. Within the next 12 to 18 months, do you expect there could be any potential upside regarding the reimbursement policies?

Alexander Johnson: Sure. And I think I lost a lot the — yes, I think I lost the last piece of your question. You’re asking changes to reimbursement. And what was the last piece?

Yi Chen: No, that was the question. Basically, your guidance — your 2024 guidance is based on current reimbursement policy, right? So I’m asking if there’s any potential, the potential improvement on reimbursement policy within the next 12 to 18 months?

Alexander Johnson: Yes. That’s I think, an opportunity for a catalyst with potential this finalization of the LCD that can — as Rob mentioned, can happen before — potentially before August. They have until August finalized. And so what’s in there, if there is an opportunity to change coverage for these Medicare patients, I think, would certainly be very impactful for our business. On top of that, we have additional studies that we’ve have in publication, whether it’s drafting or analysis KAOR or insure that can provide additional data and evidence for payers to continue to add coverage for their patient populations. And those will happen as we mentioned, at SHORE and KAOR, certainly some publications in the next 12 months.

Yi Chen: Got it. And between different types of transplant kidney, heart, lung, which type of transplant do you think — do you expect to be — to provide the largest growth driver for the top line revenue?

Alexander Johnson: Yes. I think there’s a growth right now that is in heart that’s significant. And certainly, as the billing article changed our mix a bit, heart will continue to be a good growth driver. However, the ability for kidney to come back with living donors, also we’ll continue to push that mix. Abhishek, anything else on that you want to talk about.

Abhishek Jain: I think from the opportunity standpoint, the way I see it, there are two different pieces if the billing article coverage were to get changed, with some of our data publication over our policy efforts, then of course, there is a sizable opportunity on the kidney side. As well as when I talk about the studies on the KAOR, if that data turns out to be in the right manner, then of course, there’s a significant opportunity there based on what I’ve previously called out that we have very limited commercial coverage there. So that can basically drive a fairly sizable upside. If you were to talk about the heart on the AlloSure heart primarily, I think that’s where the show comes in play. Can we get the coverage for surveillance back for greater than one year where we have limited coverage now from Medicare.

So that is another piece that will play out from the opportunity standpoint. And last but not the least, some of the health economic studies that we have been working on, how those are going to play out in some of the commercial coverage that we are trying to get on the AlloSure Heart. So I would say, again, there are multiple pieces that are in place. And to be honest, in my mind, they both are like equally in play. I called out the revenues are pretty much 50-50 between Hut kidney and the heart franchises. So I see the opportunity lie in both the areas.

Yi Chen: Thanks. And lastly, regarding the litigation expenses, is it going to be a recurring item every quarter going forward?