Here five spine surgeons discuss the challenges to innovation in spine surgery.
Ask Spine Surgeons is a weekly series of questions posed to spine surgeons around the country about clinical, business and policy issues affecting spine care. We invite all spine surgeon and specialist responses.
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Question: What are the biggest barriers to spine surgery innovation in 2016?
William Taylor, MD, Director, Spine Surgery, Vice Chairman, Division of Neurological Surgery, University of California, San Diego: The transition into coverage by insurance plans will have a negative effect on the marketplace. It may keep many stakeholders from considering new technology that has utility but cannot be brought to market. This is the biggest barrier to spine surgery innovation, coupled with the financial and procedural barriers to clinical trials.
Brian R. Gantwerker, MD, The Craniospinal Center of Los Angeles: I think the biggest barriers are the excessive and misdirected efforts of insurance companies to cut costs and maximize their profits. By arbitrarily citing outdated, misdirected and poorly applied guidelines, they stifle surgeon efforts and hence the demand for better and safer products.
Mark Nolden, MD, NorthShore Orthopaedic Institute, Chicago: The biggest barrier to innovation in spine surgery is the economic pressures of the healthcare industry as a whole. With bundled payments and other reimbursement structures, surgeons have a greater challenge to prove the new technology and implants bring with them improved patient outcomes. That requires high quality outcomes-based research, which takes time and resources. But without that extra effort, the government and third-party payers often are not willing to reimburse healthcare providers for the new technology.
Many times there is increased cost that comes with innovation, and the concern is businesses will be hesitant to develop anything new if payers ultimately don't approve its use. But with better communication in demonstrating the needed innovation is superior to what we have currently, improved patient outcomes should follow. It just might take more time and effort to get technology implemented and these devices paid for with greater government and third-party scrutiny.
Thomas A. McNally, MD, Director, Chicago Spine Center at Weiss Memorial Hospital: The lack of coverage by insurance companies is stifling to spine surgery innovation. It's been harder to try new devices and procedures because it takes so much time for staff to get approvals from insurers or for physicians to go through the appeals process. And these are all FDA-approved treatments we're recommending.
I'm also concerned that higher costs to businesses will prevent companies from innovating. Healthcare reform brought with it a medical device tax, which is making businesses hesitant to invest in development if a successful outcome is uncertain. They're the ones having to bear all the risk with a possibility of no return on their investment. In the end, the patients lose.
Neel Anand, MD, Clinical Professor of Surgery, Director, Spine Trauma, Cedars-Sinai Spine Center (Los Angeles): The biggest barrier to innovation is declining reimbursements and lack of approvals for new technologies. There is no point in innovating and spending money on research, only to have the product not be approved by the insurance companies. Despite good FDA trial outcomes, insurance companies don't approve new technologies or techniques, this kills innovation.