The story of the transcatheter aortic valve implant is well underway thanks to the fact that the Sapien valve, made by Edwards Lifesciences, is on the market, but there is more to this story. Following are three aspects of the TAVR story that bear watching.
One: Coverage does not equal adequate reimbursement
David Cohen, MD, of St. Luke's Mid-America Heart Institute took up this issue at CRT 2012. Cohen offered a number of details, but his talk boiled down to the fact that the bottom line for TAVR is written in red ink for many hospitals.
Cohen said the Medicare diagnostic-related group (DRG) system uses multipliers that adjust for several factors, explaining that for some hospitals, the arithmetic “covers the valve and not much more.” Cohen acknowledged, however, that this problem “is not unique to transcatheter valves.”
Still, the Centers for Medicare & Medicaid Services is not about to simply loose the Sapien on the cardiology landscape, so while the overall DRG system may be “quite arbitrary,” according to Cohen, it probably will not change anytime soon, at least not where TAVR devices are concerned. And it may be that CMS is okay with the fact that pricing squeezes some hospitals out of the TAVR game.
On the other hand, we all know what competition does for prices, which could open things up for some hospitals. What happens to the price of the Sapien once Medtronic gets the CoreValve to market?
Two: Off-label device use is an endangered species
I should be more specific and say off-label use is an endangered species for high unit cost technologies such as TAVR, but the beauty of the coverage memo for TAVR is that the patient has to be screened by more than one physician for appropriateness. CMS cleverly got itself off the hook for trying to suppress off-label use with the willing help of the medical societies.
This team medicine approach to patient evaluation may migrate to other technologies, though, such as artificial feet. David Armstrong, MD, of the University of Arizona Medical Center, told me earlier this year that he and other orthopedists of various stripes are growing amenable to the team medicine paradigm in conspicuous numbers.
Armstrong spoke in the context of a report about total Medicare spending on artificial feet, but part of the story there was unit cost as well. So as new technologies clamber past FDA, we can count on CMS using such screening approaches to ensure that devices that are expensive both in terms of per-item cost and aggregate expenditures will be more commonly subject to team medicine screening.
Three: Will TAVR ever completely supplant SAVR?
FDA has approved the Sapien for patients who would never survive surgical aortic valve replacement (SAVR), and thanks to another panel vote, will likely approve the device for patients at high risk of morbidity and mortality in a surgical replacement.
So what’s to stop TAVR from fully displacing SAVR? For one thing, calcification of the aortic valve root, which can be pretty readily dealt with if the chest cavity is opened up. It appears, however, that nobody has come up with a catheter-based approach.
Granted one would have to have used embolic protection devices when removing calcium build-up via catheter, but that’s the lower hurdle. If you really want to eliminate SAVR (and by implication sternotomy), you have to deal with the stroke issue seen in TAVR and fix paravalvular leak. Can’t do the second item without getting rid of the calcium build-up.
There are more chapters to the TAVR story than are enumerated here, but these are three of the more conspicuous stories. We’ll see how they evolve over time.