Becker's Spine Review

62 Dr. William C. Watters III on the Biggest Issues Facing the Industry Today Session Title: The Most Pressing Public Health Issues, Opioids, Murder Rates in Big Cities, Zika, Hospital Acquired Infections and More Time: Friday, June 23 at 9:30-10:10 a.m By Eric Oliver W illiam C. Watters III, MD, is an orthopedic physician with Houston Methodist Hospital. He has been practicing for more than 20 years and is widely respected throughout the field as well as a former North Ameri- can Spine Society president. Question: What do you think the biggest issues are facing the industry today and what can be done to fix it? Dr. William Watters: e number one is- sue 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 compa- nies and they have a broad customer base. It's obvious that innovation is not coming from these big companies. ey're mostly concerned with protecting market shares through innovation in a horizontal fashion. ey're improving on a product they already have, which re- ally is not producing any kinds of major breakthroughs or improved patient outcomes. True innovation, rather, is coming from small companies. ese start- ups 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 cumber- some. is is killing the small incubator companies, which is killing a large amount of our innovation. e 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 de- veloping 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 if you do get FDA approval." We at NASS feel we need to make a roadmap for this whole develop- mental process from FDA approval to securing an appropriate reim- bursement code to help these smaller companies, which oen have never done anything like this before. ey're out there and there is nobody to turn to and ask, "What do I do next?" ey'll get a prod- uct, do studies with it and take their research to the FDA and just get killed. ey'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. 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 crit- icized as being biased and too cost-conscious. I think the guidelines have had an impact in insurer reimbursement decisions. ey certain- ly 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 guide- lines have really improved the quality of the literature. e 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 have a sep- arate 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. Peo- ple 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 com- panies won't pay for that through the use of these guidelines. n Dr. William C. Watters III "If we can develop a roadmap for innovation, this would be incredibly helpful for the area of spine care and spine surgery in particular."

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