Brief Excerpt: St Jude Earnings Call re NCDs and LCDs

St Jude Earnings Call re Q4 2015 (brief excerpt, 1/27/2016)

So a quick update here on where we are and what our plan is around the CardioMEMS product line. As you know we got off to a quick start last year, and about mid-year we had a negative determination at First Coast, which then spiraled in to several articles resulting in [Novitas] beginning a process to make a determination.

All of that has caused a lot of unrest in the customer base on two levels, and it really is around the fear of reimbursement. The physician feedback and patient outcomes have been outstanding, and the performance of the product actually in the field is better than we had expected and better that what we had seen in the champion trial.

So the product line itself is on track. The business dynamics and the market dynamics and this is also feedback directly from our customers. This is the product that they’ve been looking for in trying to get at not only the expense but the quality of life issues of managing this disease. So we think CardioMEMS is an important clinical advancement and will in fact change the way heart failure is managed.

The process that we’re going through is first, we continue to work with the local MACs. We are making sure that they have all of the most current data, the latest data from [Lansing] was very encouraging from a real world perspective, 31 months of follow-up with a 48% reduction in hospitalization. This is significant data, and again bringing the real world perspective in the play.

At the same time, we’ve had ongoing discussion with CMS, and so the strategy is really to make sure that our customer base in informed, make sure the local MACs are informed and up-to-date with the latest data and that we’re going through the process which we will update on February 5 with CMS to apply for national coverage to make sure that we can begin to plan and begin to work with heart failure centers around the country in getting their programs up and going without a concern that they would make both time and cost commitment to find out that they could end up in a negative reimbursement situation.

So we have short term strategy, again education of the heart failure community and the MACs as well as the work that we’re doing with CMS. We think the timeline for these things will be first quarter, working its way with a submission will take anywhere from 9 to 12 months with CMS.