William C. Watters III is an orthopedic physician with Houston Methodist Hospital. He has been practicing for more than 20 years and is widely respected throughout the field.
Dr. Watters has several honors and recognitions, including being a past-president of the North American Spine Society. He was also a founding member and former chair of the NASS evidence-based guidelines committee and a founding member and former chair of the registry development committee.
Dr. Watters spoke to Becker's about the evolution of spine research since the data analytics boom and the innovation gap facing manufacturers.
Question: How has the field of spine research changed over time?
Dr. William Watters III: We're in the middle of a project at NASS where we are revising guidelines for the diagnosis and treatment of lower back pain. The original guidelines came out in 2005 by the American College of Physicians. I have been reading a large amount of data for this project so it gives me a perspective.
We've looked at the last 40 years of data and I got the following insights out of it:
In the area of basic science, European and Asian scientist are doing more and more quality work over the last ten years. We're seeing more major journal articles come from these areas, and it's really good work.
Overall, the basic science is getting better, and it's coming from more places.
With respect to clinical studies, I think the impact of evidence based medicine and all the things NASS has been talking about for the last ten years have really been spot on in the area of clinical research because the quality of the studies, and there is dsata that show this, has been increasing almost exponentially over the last decade.
The word is out: You have to do better research. If you look over the last 20 years of research, it's almost embarrassing to look at the stuff I used to quote routinely as being quality papers, when they were basic things we wouldn't even write today.
Those are the kinds of things that are coming down the line that we didn't see 10 years ago.
Q: What kind of changes has the NASS's evidence based guidelines committee accomplished?
WW: I think we are seeing varying degrees of effectiveness at different levels.
In terms of policy or insurance payments, these guidelines have had an impact. Insurers are willing to look at these as sources of expertise beyond their own proprietary guidelines, which they have been criticized as being biased and too cost-conscious. I think the guideliens have had an impact in insurer reimbursement decisions. They certainly have had an impact on healthcare policy at many levels.
In terms of research, we've seen the guidelines set the bar higher on the kinds of evidence that is being produced in the clinical realm. I think the evidence based techniques and the development of guidelines have really improved the quality of the literature.
The other benefit they have had is they identify where the gaps are in our knowledge base are. For example someone will see there is no good research on the effectiveness of back braces and a physician will go "I'll look into that." NASS and their research foundation has a separate area where they list all the gaps in knowledge they found in their guidelines, and they're willing to fund research to bridge these gaps.
At the practice level I think the impact has been the least obvious. People take a long time to change their practices, which is understandable, but I do think we're seeing a higher quality of medicine practiced when you follow these guidelines. It's a push down from the insurers. If you're used to doing a fusion for a simple disc herniation, the insurance companies won't pay for that through the use of these guidelines.
Q: What do you think the biggest issues are facing the industry today, and what can be done to fix it?
WW: The number one issue is increasing regulation and downward reimbursement is really making it tough for the practicing physician and the manufacturers.
Big manufacturers are shielded because they're international companies and they have a broad customer base. It's obvious that innovation is not coming from these big companies. They're mostly concerned with protecting market shares through innovation in a horizontal fashion. They're improving on a product they already have, which really is not producing any kinds of major breakthroughs or improved patient outcomes.
True innovation, rather, is coming from small companies. These startups are having a rough go of it. It is scary that last year for the first time more than 50 percent of innovation in these areas has moved offshore and out of America.
One of the reasons for this is our regulatory structure is very cumbersome. This is killing the small incubator companies, which is killing a large amount of our innovation. The big companies have given up innovating, and it falls to the small companies that are sustained with venture capital, which is becoming less and less likely. It's not a good system right now.
What can be done (to fix it) is taking the incubator companies and developing an informational approach to them that says "Here's where you're going to stumble. Here's the regulatory issues you have to worry about, Here are the likely hurtles at FDA – design your studies to anticipate them. Here's how you should approach CPT coding so you can figure out how you're going to get paid for your device this if you do get FDA approval.
We at NASS feel we need to make a roadmap for this whole developmental process from FDA approval to securing an appropriate reimbursement code to help these smaller companies, which often have never done anything like this before. They're out there and there is nobody to turn to and ask 'What do I do next?' They'll get a product, do studies with it and take their research to the FDA and just get killed. They'll hear 'You did everything wrong!'
If we can develop a roadmap for innovation, this would be incredibly helpful for the area of spine care and spine surgery in particular. NASS is seriously trying to do this currently to foster innovation in these areas.
Learn more from Dr. Watters at the 15th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference + The Future of Spine in June 2017! Click here for more information.
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