Issue link: https://beckershealthcare.uberflip.com/i/346340
43 Data Transparency I n August 2013, the Physician Payment Sunshine Act went into effect, meaning industry interactions with physicians were recorded and published online. The first set of interac- tions published on the Centers for Medicare and Medicaid Ser- vices website were in September 2014, leading some physicians to think twice about how they relate to device companies. "I think surgeons don't want to deal with the fall out and don't want their data out there," says Frank M. Phillips, MD, professor of ortho- paedic surgery at Rush University Medical Center and co-director of the Minimally Invasive Spine Institute at Midwest Orthopaedics at Rush in Chicago. "There are innovative spinal surgeons who are avoiding working with industry because of the negative connota- tions that have been created by legislators and the media. Surgeon inventors have been vilified for receiving royalty payments from im- plant manufacturers for products they have developed." There are few other funding sources beyond device companies for clinical trials. The federal government has limited grants for research and specialty organizations such as the Orthopaedic Re- search Education Foundation have some resources to doll out, but not enough to fund most of the projects in the field today. "It's very rigorous to gain these limited government funds to conduct research. Government funds are limited and so are the research funds from the industry and it's becoming more expen- sive for industry to conduct clinical trials in the United States," says A. Nick Shamie, MD, chief of orthopedic spine surgery at UCLA Health Systems. Impact on relationships There are some legitimate relationships that result in large payments for surgeons, and not all surgeons shy away from it. "There are some surgeons who are receiving huge amounts from the industry, and that's because they are making a significant contribution to the development of implants and teaching new procedures," says Michael Hisey, MD, of Texas Back Institute in Plano. "If you look at it as a bad thing, you're missing the boat. It's really a positive that surgeons are able to spend some of their time advancing the progress of medicine. I would be proud when it comes out that I'm a consultant to companies because I've put a lot of work into those products." But has the legislation been effective? "With increased scrutiny and transparency, questionable un- ethical surgeon consulting relationships have decreased which is a good thing. But at the same time, the wedge driven between surgeons and implant manufacturers has slowed opportuni- ties for collaborative innovation to improve patient outcomes," says Dr. Phillips. "Interestingly, we've looked at how patients perceive surgeons participating in product development and receiving remuneration for this. Patients don't seem to mind these relationships as long as they are ethical. In fact, many pa- tients think it's a plus to have innovative surgeons performing their procedures." Even though some inappropriate relationships have ended, there will still likely be cases where surgeons don't follow the rules. "The people who have unhealthy relationships and receive kick- backs are the last people who are disclosing that information," says Dr. Hisey. "Instead, we have a lot of people who are disclos- ing their relationships, but they aren't part of the problem. You aren't going to catch the bad actors with disclosures because they are already breaking the rules." Relationship transparency Co-director of the Minimally Invasive Spine Institute at Rush, Kern Singh, MD, likes the Sunshine Act because it has made the field more transparent. He always tells his patients disclosures up- front. "If I designed the implant I want to use, I go through that with my patients," he says. "Patients like it and they see me as inno- vative. They understand why I have relationships with the device company. I think the Sunshine Act is the right thing to do." Transparency is a huge trend in healthcare and disclosures are routine for surgeons presenting research or discussing which de- vices they'll use with their patients. "We've seen so much in the way of surgeon disclosures over the past decade, that we've become desensitized," says Dr. Phillips. "Gener- ally most clinicians understand the need for surgeons to drive device innovation which may lead to conflicts of interest. When surgeon developers present their data, most surgeons take the conflict of in- terest with a grain of salt and assess the data based on its merits." Academic spine surgeons may be feeling the pinch more than most; they are often involved in research activities and publish- ing data on new products, and those studies take time and effort to complete, which must be compensated because of the addi- tional staff required to run these trials. "There are several people involved in the research projects, from the surgeons to the bookkeepers and staff who are working with patients to fill out their forms and collect information," says Dr. Shamie. "It's a very rigorous process. Who is going to pay for that process? If my staff are inundated with paperwork, do I just have them work for free or is there a fair remuneration? Some institu- tions have limited the remuneration so much that it makes being involved in clinical trials cost-prohibitive." Some private practice surgeons are now becoming involved in re- search as well and may not face the same scrutiny from their in- stitution. "We need to work through these challenges, and that will require a concerted effort to make the decision-makers aware of the importance of surgeon involvement from a wide spectrum of back- grounds; public and private sectors; academic and non-academic institutions.," says Dr. Shamie. "If we limit the big institutions from getting involved, we are skewing the data, especially by limiting pub- lic institutions that are sometimes held to a higher standard." Media controversy The media frenzy around the most egregious inappropriate re- lationships has somewhat negatively impacted the perception of these relationships. "The media skews the conversation around the surgeon/company relationship, which is necessary in the field," says Dr. Singh. "The engineers don't have clinical sensi- bilities. You can come up with the best widget, but if you don't know how to employ it in a clinical setting, it won't make it to the hospital. I hope the perception never gets to the point where surgeons can't be involved in this development at all." Many of the biggest innovations over the past quarter-century have come as a result of surgeons partnering with device companies. Since surgeons work in the field every day, they have a unique per- spective on what designs and developments would make their job easier and improve patient outcomes. Post Sunshine Act: How Spine Surgeon Relationships With Industry Are Evolving By Laura Dyrda Dr. Frank Phillips Dr. Nick Shamie Dr. Michael Hisey Dr. Kern Singh Dr. Hyun Bae