Dr. Frank Phillips: From my point of view, having been involved in this space for some time, it is exciting to see minimally invasive surgery gaining widespread acceptance. With the development of enabling technologies as well as enhanced surgeon training — in particular exposure of young surgeons to MIS during their formal training — the procedures can be done more reliably, reproducibly and effectively. Spine surgeons and the public are starting to see it as something that is mainstream and effective. It's really taking off, and that's exciting.
On a personal level, having been involved in lateral interbody fusion (XLIF) since its inception, it is gratifying to see the outstanding outcomes being achieved with this procedure for a variety of surgical indications.
Q: What difficulties are there in the minimally invasive spine market right now?
FP: Payors are pushing back on lumbar fusion surgery in general, putting up as many roadblocks as they can. Also, the FDA process has slowed and getting approval for new technologies has become more expensive and less predictable. These uncertainties have led to the efflux of capital from the spine market and as a result innovation has slowed considerably.
Q: What effect will the excise tax have on innovation?
FP: In my opinion, the 2.3 percent medical excise tax in the Patient Protection and Affordable Care Act will decrease spine companies' appetite for innovation. These companies that will be paying the excise tax off their top-line will no doubt look for ways to reduce expenses and spending. I am concerned that this will result in scaling back on potentially game-changing but higher-risk product R and D.
Q: What will it take for more spine surgeons to adopt minimally invasive techniques?
FP: I believe that the biggest limiting factor has been surgeons questioning whether the downside of struggling through an initial learning phase is commensurate with the clinical advantages of minimally invasive spine surgery. Minimally invasive surgery involves a different skill set and anatomic appreciation to open spinal surgery. Not all "open" spine surgeons have the ability or aptitude to make this transition.
Ultimately, I think adoption of minimally invasive surgery will have to be driven by high-quality evidence and high-quality independent training programs. Traditionally, hands-on training has been done primarily by device companies. This is not an ideal training venue to help surgeons become facile with procedures and get them over the learning curve. But, the training process is evolving. There is a strong push now in surgeon education, to train surgeons through each step of a procedure with the surgeon being required to demonstrate competency throughout.
As far as the evidence goes, studies repeatedly show at least equivalent clinical outcomes can be achieved with certain minimally invasive procedures when compared to their open counterparts, with reduced lengths of stay, blood loss, surgical time, complications, morbidity and expenses. In my own practice, there are certain procedures, such as a TLIF, in which I can't honestly justify doing that procedure open. On the other hand, other questionable "fringe" minimally invasive procedures will not withstand the scrutiny of quality studies.
Q: What are some of the biggest challenges with reimbursement for minimally invasive surgery?
FP: The challenges with reimbursement, in the world we are in today, are a battle over lumbar fusions in general. There's an effort to reduce the number of lumbar surgeries being done. Only occasionally have there been unique minimally invasive challenges, unless the procedures involve a deviation from well-accepted, validated spine surgical principles.
However, spine surgeons do run into issues with denials. In many instances health coverage guidelines cited in these denials are non-transparent, involve little input from clinicians in the field and selectively cite articles to reach pre-determined conclusions. Further, the guidelines are often dated. Lumbar fusion is expensive and payors don't want to pay for it.
Q: How can surgeons overcome those denials?
FP: In the end, it comes down to data and studies. To be fair, up until the last decade, we probably haven't done a great job of collecting data using metrics that matter to the various constituents. Spine surgeons traditionally focus on metrics like rates of fusion, correction on deformity or detailed radiographic parameters that are irrelevant to payors. They care about the cost and the value. The more studies we do on broader issues of cost and value, the more clout we'll have moving forward. We have many studies supporting the effectiveness and value of many spinal procedures, but have done a poor job of getting this message out.
Q: Where is minimally invasive spine surgery headed?
FP: It's going to become more mainstream, the standard for many procedures. I think minimally invasive techniques will move spine surgeries to outpatient or overnight stays, which is already happening. Minimally invasive technique will also keep costs down and improve patient satisfaction.
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