It’s more on the timing and the smoothness of the transition from TPT to a permanent APC assignment. And the reason why there’s some risk around this is because there’s a lack of synchronization between the transitional pass-through calendar, which is quarterly in the APC calendar, which is typically addressed on an annual basis via the CMS’s rulemaking process. So the TPT program ends on June 30, 2024, which is obviously in the middle of the year. CMS could decide to address the TPT transition in the 2024 rule or the 2025 rule. So if CMS were to wait until the 2025 rulemaking to address the transition to an APC, then there would conceivably be a six month gap between additional payment being available by a transitional pass-through, which will be in place for the first half of 2024, and additional payment via an APC assignment that would go into effect in January 2025.
So we’re aware of this, of course, ShockWave and our partners from the interventional community have therefore asked CMS to address the transition — from transitional pass-through to an APC assignment in the 2024 rule. So as I mentioned a moment ago, the — we believe that the data is clear, compelling, it’s stable and it’s the luminous. We believe the procedure level coding is in place and frankly, there’s just sort of the importance of coronary IVL and how quickly it’s become a critical tool in PCI. So in the short time that it’s been on the market, IVL has become the most widely used plaque modification tool in PCI. And also, as we’ve seen, as was mentioned earlier in the call from recent expert consensus statements from the medical society, it’s uniquely beneficial in female patients, suggesting that IVL could be frontline therapy for women.
And it also enables patients in rural areas to receive treatment for their complex disease and nearby hospitals without having to be transferred to far away hospital that has on-site cardiac surgery. So we believe these issues are also important to CMS, and they’re aware of these unique advancements, and we believe that CMS will consider these in their decision whether to address coronary IVL in 2024 or wait until 2025 to make APC assignment. But I just want to point out that even if it winds up being 2025, we believe that the risk or impact of the business would certainly be short term and manageable. We’re talking about six months. And as stated previously, coronary IVL has become an important therapy in PCI. And I would also mention that while that might be sort of a counter current from a reimbursement perspective, the sort of tailwind would be that there would be a CPT code in place that will remunerate physicians.
So there’s a few factors to balance here Adam. But I just wanted to take a moment to kind of elaborate on the situation and why ShockWave remain confident — are confident in the prospects.
Adam Maeder: That’s very helpful, Rob. I appreciate the fulsome response and thanks for the color there, Doug. Maybe for the follow-up, I wanted to ask about U.S. coronary growth where the story is really all about utilization and same-store sales growth in ’23. I think there were some comments in the prepared remarks about the different levers that you’re going to pull on, but I was hoping you could just kind of flush that out a little bit more how you plan to walk your customers up the adoption curve, drive center utilization, whether it’s C2+, nodular calcium, the construction of the sales force? Just any more color there would be much appreciated. Thank you.
