At the 2013 NASS Annual Meeting, Joseph S. Cheng, MD, MS, associate professor of neurologic surgery and orthopedic surgery and director of the neurosurgery spine program at Vanderbilt University gave a presentation titled "Who's to Blame? When Physicians Rely on Medical Device Representatives for Instruction."
This past year the Physician Sunshine Act went into effect and now requires anything more than $10 to be reported as a transaction between the physician and device representatives. Even representatives giving surgeons a journal article that would equal $10 or more to access must be reported because it's perceived as something of value.
"Can we rely on our representatives to give us the information we need to use their products when it comes across as coercion because it's going to be reported that they gave us a payment of some sort?" Dr. Cheng asked. Typically, spine device companies have instructional courses on using their products and surgeons rely on these companies to educate them on new procedures.
What about the quality of the training? If surgeons aren't trained well enough before beginning to use new equipment, can they blame the device company for not adequately training them? In a recent case, patients who experienced complications after surgeons performed procedures using Intuitive Surgical robotic devices sued the company, alleging the company did not adequately train their surgeons.
Another issue can arise when patients experience complications after off-label use of a product. Is the surgeon responsible? In a recent case, patients filed lawsuits against both the physician and device company after experiencing complications with their pain pump; then the device company turned around and sued the physician as well for using the product off-label.
Whether or not device representatives should be allowed in the operating room is another topic of hot debate today. One issue with bringing the device representatives into the OR is up-selling — when representatives show surgeons new products instead of allowing them to use the "tried and true" implants that are less expensive.
The device representative, or another party, may also give bad advice on coding for specific devices.
"Who is responsible for coding education?" said Dr. Cheng. Inappropriately coded devices could spell disaster for spine surgeons. "The big deal is that Medicare and other insurance companies can pick up on this pretty quickly."
In recent news, physicians are being held palpable for overcharging Medicare, which is considered fraud. "The problem is, what happens if they get that instruction and they say they heard it from [someone else]," Dr. Cheng said. In one instance, a surgeon performed minimally invasive interbody fusion and was told it could be coded as a regular open fusion PLIF code.
"Because there is no code for percutaneous interbody fusions per se, it was supposed to be unlisted, and he got audited. The question is who is responsible for this? Was it the surgeon who says this is what I was told to do? Who is responsible for the $190,000 they were asked to be paid back? Is it the person who gave them that advice in the first place? Is it both?" said Dr. Cheng.
To close the session, Dr. Cheng posed the questions about the necessity for a strategic response to the physician-representative relationship and how much responsibility NASS has when issues arise.