Ann: Proposed USA Medicare Changes, page-45

Cheers for providing the alternative view, definitely important to think about both sides!

I think there is a bit more than just a positive spin here. SGHT tried putting a positive spin on their announcement and look what happened to them. Unlike that company's product, iTrack Advance is actually still covered for the ab externo approach even in the worst case scenario (where all the other MACs finalise the LCD). On the other hand, Omni cannot do any form of canaloplasty full stop. Also, unlike Sight Sciences, Nova Eye Medical has come out firmly stating that they still see continued sales growth even despite the LCD. These guys have always been quite spot on when it comes to their sales outlook...

Now the other MACs definitely cannot change the LCDs to include iTrack Advance as non-covered. I posted the specific chapter of the PIM (chapter 13.2.4) which clearly states that they (legally) do not have that ability, not unless they wish to go through the entire LCD process again. They can only now make minor adjustments, or completely retire the LCD. They are not allowed to add a device as non-covered to this current LCD unless it was proposed in the initial LCD.

The company actually seemed to frame their view of the potential impact with the assumption of the worst case scenario, where the other MACs follow WPS in making the ab interno approach non covered, but they believe that this will be offset by the fact that iTrack Advance will be the only device that can still be used for canaloplasty (albeit, using the ab externo approach). So even in the worst case scenario, iTrack Advance will remain the only covered procedure for canaloplasty, providing the opportunity to expand market share. This is worst case though, and it is still likely that the other MACs will not finalise LCDs (if they were going to, they usually do them at the same time, the fact they have not indicates disagreement). It is even more likely that they will be successful in appealing the decision. As I posted above, WPS significantly deviated from the norm in relation to its evaluation of the quality of clinical evidence for iTrack Advance. I don't believe the company will have trouble justifying the clinical evidence supporting its procedure, as it is quite high relative to other types of procedures.

In relation to whether or not the doctors will want to use the ab externo approach, well we will have to see. Given it is now the only reimbursed canaloplasty option, and it still has significantly better reimbursement than stents, I think there is a good chance. It is not significantly different to ab interno, and any surgeon can still perform it. All the advantages of the new iTrack Advance device are still retained as well. They are pretty much equal in terms of safety and efficacy, and even almost equal in terms of efficiency (due to the new improvements to iTrack Advance). The incision is the only real difference, but it is not really difficult at all for a trained surgeon and is still very safe.


In terms of catalysts, 2RT is of course more speculative, but I see there being a good chance that we will get an announcement before the end of the year. But we are definitely due for a sales update this month, and I expect it will be very bullish. There is also still a good chance that the other MACs may just decide to drop the proposed LCD this month, which would also provide a major catalyst. If that doesn't happen though, we should get an announcement in about a month stating that the appeals process has begun, and that a stay has been imposed on the implementation of the final LCD (meaning we should actually maintain coverage for at least several months beyond December for all methods of canaloplasty whilst the appeals process is being undertaken). I think it will end up being a very busy next few months...