Everyone has heard about the FDA advisory hearing for the Absorb scaffold by Abbott Vascular, but to recap, one of the issues that came up in connection with the trial data for the Absorb was the association between coronary artery vessel size and adverse events such as thrombosis. There was some question of whether intravascular ultrasound (IVUS) would be useful in cutting down on such events, maybe not a bad idea in principal given that the Absorb's struts are much thicker than those found in conventional device struts.
But that was just the beginning of the IVUS conversation. Several days later, I got involved in a Twitter conversation about all this with a couple of writers who know the cardiology space a lot better than I do, and I thought it might be interesting to bring this conversation to light here at MDD Perspectives.
No FDA mandate
One of the members of the advisory panel for the Absorb had remarked that IVUS or OCT (I'm not sure which offhand, but I think he had said IVUS) is not routinely used for placement of coronary artery stents, but there was some disagreement in the Twitter discussion as to whether the evidence behind such uses of IVUS is particularly robust.
It struck me that there was some question in this Twitter discussion of whether FDA can mandate IVUS during placement of the Absorb, but that seems like a practice-of-medicine debate. If that's the case, I don't think the agency can pull that off quite yet.
Beyond that, I'm not sure payers would cover such imaging procedures in the absence of some compelling data. One item in the literature in support of IVUS showed up last year in JAMA, but payers are going to want more than one study about stents going into vessels with lesions at least 28 millimeters long. Plus the study was conducted in Korea.
I'm not saying this is all the data that are available for this conversation, but if this is all there is, I'd point out that FDA probably wouldn't take it at face value because it's an OUS study. And I see no reason payers would react differently. It'll be interesting to see whether this issue gets any bandwidth at the April 1-4 American College of Cardiology gabfest, too.
What are Abbott's imperatives
On the other hand, one might think Abbott will try to discourage docs from dropping this device in patients whose vessels are in that danger zone for thrombosis. Assuming that's the case, this would seem to take some of the wind out of the IVUS discussion (it also strikes the casual observer that the last thing this company's investors want is another "DES trauma," as some at FDA described the late-stent thrombosis episode).
There are among a number of scribes who know cardiology a lot better than I do, so I can't take sides in the utility-of-IVUS debate without having to answer uncomfortable questions about why I think A and not B. All the same, I'm thinking that for at least the next year or two, the Absorb will go into those wider vessels without the benefits of IVUS, whatever they may be.
[caption id="attachment_4657" align="alignleft" width="205"]Costello and that other guy [/caption]
Now that Abbott Vascular has pulled out a resounding win at an FDA advisory committee for its Absorb bioresorbable scaffold, it's time to ask what the coverage and reimbursement pictures look like. The coverage part looks easy – perhaps easier than it really is – but it may be more helpful to ask who will be first to give the Absorb a look via the reasonable and necessary lens.
CPT + MAC = OMG
The easy part of the Absorb situation is the diagnostic-related group discussion because it presumably folds neatly into the same category as drug-eluting stents. Medicare does not have to reinvent any wheels here, and so neither does Abbott.
Consequently, Abbott is likely to appeal to the Centers for Medicare and Medicaid Services for a new technology add-on payment (NTAP) for the Absorb. However, the deadline has passed for the NTAP for fiscal year 2017, so the company will have to wait for FY 2018 to get a payment the company will likely need to cover the cost of the device, which is almost certainly more expensive than drug-eluting stents.
One way of looking at this is to ask what happens when the American Medical Association meets to come up with a CPT code for the device. It seems likely that the Absorb will end up with a category III CPT code, and device makers seem to be of the view that this is the beginning of trouble where Medicare administrative contractors (MACs) are concerned.
It has been argued that MACs are inclined to see anything with a category III code as non-coverable because this category is applied to devices that are investigational and/or experimental, and the problem is pronounced enough that the 21st Century Cures bill (H.R. 6) has provisions that would change how MACs handle such situations. This all goes a long way to explaining why the Absorb's Medicare problems may start with the CPT-MAC discussion.
Costello to Abbott; You throw it to who?
Before we dismiss this as an entirely speculative line of thinking, lets not forget the fate of the CardioMEMS device by St. Jude Medical. St. Jude had picked up both an NTAP and a new technology pass-through payment for the system to cover both the implant and the out-patient follow-up, but that did not prevent First Coast Service Options from declaring the device investigational and thus non-covered. Another MAC, Novitas Solutions, has offered clinical trial coverage for the CardioMEMS, but that's probably not what St. Jude Medical had in mind when it acquired the device from its namesake company of origin.
It may be premature to say that FDA will give the Absorb a nod in the near term, especially when one considers that the agency clearly demonstrated an interest in more data from the pivotal trial, but let's assume for the moment that FDA will approve the device before the end of the year.
In this scenario, the AMA committee charged with assigning CPT codes will surely get to the Absorb long before CMS has a shot at the NTAP question, which leaves the field open for the MACs. If recent history is any indication, this is where the real coverage headaches will begin for Abbott, which may have to absorb a lot more costs associated with this device before it can generate any ROI in the U.S. market.