Saturday, November 28, 2009

The Year of Living Dangerously

No readers, this isn't about the 1982 Peter Weir film adopted from a book by the same name. As "the year of living dangerously" winds down, the question looms, what lies in store for spine in 2010? Based on recent articles, 2010 will be a year of change. On Monday, November 30th, NuVasive will hold a conference call to quell the recent "hullabaloo" regarding XLIF as a preemptive move to assuage the anxiety from the Street, and to reassure everyone that all is well with XLIF. TSB must pose some questions for our readers. If the insurance companies cannot distinguish the difference between an XLIF and ALIF, how is it that NuVasive can? Isn't that the platform this procedure was built upon? Is or isn't the XLIF a different procedural approach? Let's forget about coding for a minute, is it an ALIF, or, is it an XLIF? So in the spirit of intellectual debate, will this become a coding issue, or, a reimbursement issue? If the insurance industry has placed a bullseye on XLIF, this will be a challenge for NuVasive, considering this "procedural product" has been its major revenue generator. In the end, could this really be about lowering the reimbursement as a response by the payors to a host of new products introduced by the competition? Spare me the ours is better than theirs, TSB wants to know what our readers think?

It is interesting that after TSB posted "Requiem for NASS" there was an interview published with incoming NASS President Ray Baker, M.D. about the overall strength of the organization. Of course, Dr. Baker's position is that NASS is stronger than ever, would we expect otherwise? TSB would never argue with membership numbers, but as Peggy Lee once sang;

"Is that all their is, is that all their is,
if that's all there is my friends, then let's keep dancing,
let's break out the booze and have a party, if that's all..... there is?"

It's nice to know that NASS is willing to stand by their men, I'm sure Tammy Wynette would be proud, but it has been a challenging year for NASS. Do the names Kuklo, Polly, Wang and the recently convicted Kabins ring a bell? Granted Kuklo, Polly and Wang have different issues, yet, too much negative publicity has left this organization on the defensive, and will continue to leave many unanswered questions about the role that surgeons play (some rightfully so) influencing commercial enterprise. If the advertising industry is looking for a replacement for the late Billy Mays, there isn't a shortage of personal spokespeople in the aforemetioned group, excluding Kabins.

The industry will see a major shift in product development, engineering, manufacturing, and clinical studies. This has been in the works for the last three to five years considering that some articles make it sound as though this has been a recent phenomena. We will see more outsourcing to China, Korea, India, and Malaysia. This really isn't about the FDA, this is really about cutting the cost of R&D/engineering and manufacturing resulting in maximizing gross margins! Based on TSB's exposure to medical manufacturing in foreign countries, someone will have to be responsible to monitor quality manufacturing? Products still have to meet the same validation process. Inevitably, product safety comes back to the FDA. Before any judgement can be made, all one has to do is look at the healthcare system in many of these countries. This isn't really about who offers "breakthrough" medical care, this is about money!

So, as we head into a New Year, TSB must ask our readers, who will be the headliners, and who will be the legends? We want to know what you think?

1 comment:

  1. Keep up the great work, TSB! You continue to pose all the right questions....