Becker's Spine Review

31 PRACTICE MANAGEMENT Florida health system eliminates orthopedics at 2 clinics after $6.8M loss last year By Laura Dyrda T wo clinics that added orthopedics at the University of Central Florida's College of Medicine lost millions of dollars last year, according to the Orlando Senti- nel. The clinics were launched in the hopes of boosting revenue and supporting the faculty practice's solvency, but instead they lost $6.8 million last year. The college of medicine Dean Deborah German told the Sentinel that the practice didn't have the infrastructure to support orthopedics, nor an understanding of what the specialty would entail. Since the beginning of 2019, three orthopedic surgeons have resigned and one had his position eliminated. To sty- mie future losses, the clinics will no longer include ortho- pedics. Adding orthopedics was just one aspect of a turnaround plan for the clinics, which lost $5.8 million in 2016-17. UCF Health also invested in a new EMR, competitive compen- sation packages and consultants in the attempt to improve the clinics' financial situation. n The state of BMP in spine surgery today By Angie Stewart A t the North American Spine Society Annual Meeting, in a Sept. 25 panel session titled "BMP in 2019 – e Biologic Hasn't Changed but the Evidence Has," a group of physicians discussed the state of BMP today. e panel included Eugene Carragee, MD, Wellington Hsu, MD, Greg Schroder, MD, Chris Chaput, MD, and Peter Whang, MD. e panel was moderated by Harry Smith, MD. BMP was initially developed for hard- to-fuse patients, including those that need- ed multilevel procedures and had other co- morbidities. But aer further development, Medtronic brought BMP to the market as a device: Infuse. Infuse received initial FDA clearance for sin- gle-level ALIF procedures in 2002 and the clinical trials revealed positive results with few adverse events. However, BMP came un- der scrutiny as surgeons began experiencing complications and publishing peer review articles based on their findings. e Yale Open Data Access Project launched in 2011 to examine the original data from the industry-sponsored studies. e project rep- resented a new model for evaluating indus- try-sponsored clinical trials to foster public trust while minimizing risk and maximizing benefit to patients. Medtronic supported the project with a $2.5 million grant and provid- ed all data for independent review. Dr. Whang reviewed the original YODA studies, which were published in the Annals of Internal Medicine in 2013. He outlined the findings in these studies, examining the potential for increased adverse events and cancer risk. "In summary, there could be potentially some benefits in terms of fusion rate and disability for Infuse versus iliac crest bone gra," said Dr. Whang "In terms of safety, there are some concerns with early back and leg pain, potential for cancer risk, although it was less apparent aer two years, but the overall adverse events and specific adverse event risks were not significantly different." Dr. Schroder discussed the data post-YODA. Since then, there have been 650 different studies published examining BMP, including 80 in 2019 so far. He pointed specifically to a prospective randomized trial from Canada, including 197 patients at eight centers, found BMP had an increased rate of fusion com- pared to those with iliac crest fusion. How- ever, there was no difference on health-relat- ed quality of life outcomes at two and four years. He concluded that the post-YODA data didn't show evidence that BMP caused cancer. Dr. Hsu talked about BMP use today, outlin- ing the "hype curve" history of initial rapid adoption, steep utilization drop, and then steady growth again in BMP use. "We have seen the evidence to show that perhaps the complications that we were exposed to, was really because we were over-zealous in use and perhaps not as much from the actual product," he said. He argued it's more reason- able for surgeons to adopt technology more judiciously in the future. ere are two clinical trials examining Infuse today, sponsored by Medtronic. e first is a posterolateral fusions trial first posted in 2017 with an expected completion date of next year. e second trial is for transforam- inal lumbar interbody fusion procedures. e company plans to recruit up to 1,000 patients to participate at around 50 sites in the TLIF study. Dr. Hsu went on to report that in 2011, BMP revenue was around $900 million and then dropped to $504 million at its nadir; since then, BMP revenue has had an average annu- al growth rate of 7.5 percent. In 2010, growth factors comprised almost 50 percent of the bone gras that were used, but this was cut in half over the following five years as new articles were published, reported Dr. Hsu. "I think aer the next four, five, six or seven years, we will see growth in the use of growth factors as more evidence comes out," Dr. Hsu said. In a statement, Medtronic praised the dis- cussion of BMP and Infuse at the meeting and went on to state: "Medtronic believes in the safety and effectiveness of Infuse for approved indications. We're committed to advancing the evidence of Infuse to support physicians as they make decisions about treatment options. In addition, we're com- mitted to offering a broad range of bone gra technologies to help physicians address a spectrum of patient needs." n

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