ShockWave Medical, Inc. (NASDAQ:SWAV) Q4 2022 Earnings Call Transcript

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Doug Godshall: Okay. Great. And one of the reasons I’m confident is because Rob Fletcher, our Vice President, Marketing and Market Access is running the program, who also happens to be on the call. So I’ll do a very brief overview and then hand it to Rob. So NTAP, as you pointed out, sunset this year, that’s for inpatient procedures. It is not what drives decision-making or perception of reimbursement in interventional procedures generally, both peripheral and coronary. And then TPT is sunsetting next year in the July time frame. And we’ve been very focused on strategies for ensuring that there is — that we have a strong path going forward to prepare for that sunsetting. And I’ll let Rob sort of provide a perspective on how we’re approaching that and why we feel really good about where things will land ultimately.

Rob Fletcher: Hi, everyone. Thanks, Adam, for the question. Can you guys hear me okay?

Doug Godshall: Yes.

Rob Fletcher: Great. Yes. So Adam, I’d like to take this opportunity to give some background into this — some of the issues that you’ve raised here. And let’s start with the transitional pass-through because I think that’s what’s probably most on everybody’s mind. So obviously, all transitional pass-through programs, a temporary nature that come to an end. And it’s CMS’s routine business to analyze the data collected and make a determination on how and how much to pay. So there’s two main things you need to successfully transition off of a transitional pass-through program. One, you need a procedure level code that hospitals can use to get payment after the program ends. So a new Category 1 CPT code for coronary IVL procedures will become effective on January 1, 2024.

So check, that’s in place. Second, you need cost data that is sufficient in volume and meets the criteria for that higher APC assignment. So uptake of coronary IVL as you know, has been very rapid, which also means that there’s a large volume of claims data with which CMS can analyze and make their determinations. We have, of course, analyzed Medicare’s claims data following their methodology and applying their criteria. I can say that the data are compelling. We meet criteria for the higher APC that is APC-5194, and we meet it now. I’d suspect that the scenario, though, that investors are really concerned about is the scenario where if after the TPT ends, payment falls back down to the baseline APC, thereby leaving no additional payment for coronary IVL.

And this is an understandable concern because it’s happened before to other technologies in MedTech history. But we think this risk is very low, and that’s because the data is very clear and compelling. We’re not teetering on the edge of the criteria, we’re well past it. We’ve been continually refreshing the analysis as data continues to roll in from the program. The conclusion has been stable and consistent that we meet criteria for the higher APC. So CMS makes database decisions, and they’re going to do so with this TPT program as well. I can tell you that coronary IVL clearly does not fit into the baseline APC. So therefore, we really do not see this as much of a risk. So for investors, and you kind of mentioned this, Adam, I’d like to put forward that the risk really isn’t in the payment going away from our view.

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