Here are five spine industry experts on the biggest challenges currently facing the industry. William C. Watters III, MD, North American Spine Society President, Spine Surgeon, The Baylor College of Medicine, Houston: One of the largest challenges currently facing the spinal implant industry is the downward pressure on reimbursements across the healthcare system. Decreased physician reimbursements have increased the attractiveness of physician-owned distributorships (PODs), cutting into manufacturers' profits. Depending on how the regulatory questions associated with PODs play out, this might or might not be a problem for major manufacturers.
This same downward pressure on reimbursement is definitely affecting the profitability of the industry's products directly as well. Furthermore, increased control on the healthcare system and increased scrutiny of industry's marketing and promotion of its products is likely to cut into profitability even further.
A more subtle challenge facing the industry at large is the reliance on horizontal technological development with the development of similar products across manufacturers to the detriment of innovative new products. Pedicle screw systems are a good example. There really is no dire clinical need for the plethora of systems on the market. Each represents at most an incremental improvement over others often with an increased cost to use and no significant benefit or improvement in comparative effectiveness.
The huge amount of development and marketing cost spent on these systems alone could well be applied to development in biologics or other advanced technologies.
Daniel Resnick, MD, Neurosurgeon, Professor of Neurological Surgery at the University of Wisconsin School of Medicine and Public Health, Madison: Cynicism and growing distrust from the public and from spine care providers [are the biggest challenges]. The promotion of new products based on shoddy or no data does a disservice to our field and must be curtailed.
Eeric Truumees, MD, Spine Surgeon, Seton Spine and Scoliosis Center in Austin, Texas: Spine surgery is expensive. Back pain and sciatica rarely kill people. Those facts put us in the crosshairs of payers. Similarly, the implant industry will face increasing pressure to offer the same implants for less money. A major aspect of this challenge arises from the fact that most commercial payers look at the value equation over a relatively short time horizon. The benefits of optimal spine care, for example sagittal rebalancing, make take years to be revealed.
Additionally, spine care has a huge impact on non-medical/social costs. These costs are far too infrequently taken into account when determining the true value of a spine intervention. The benefits to the employer, the family and society at large of getting a spine patient back to function must be included in cost per quality adjusted life year calculus. Often, the spine intervention will have negative cost or net savings to society.
Here too, the best way to address these challenges lies in how we tell the story. Bickering with primary care or the radiologists about pieces of the pie and infighting with non-surgical spine care specialists will only detract from our ability to make our case to payers and lawmakers. Instead, we need to learn the language of medical economics. We need to speak a common language in terms of patient reported outcomes. We have to fight CMS's and payers' efforts to use proxy measures like satisfaction and process measures like readmissions as their main measures of quality of care. Most importantly, we need the data to support the quality and, over the mid- and long-term, cost-effectiveness, of the care we deliver.
Christopher Kauffman, MD, Spine Surgeon, Premier Orthopaedics in Nashville, Tenn.: The biggest challenges facing the industry today and in the future are how they will perform clinical trials on the new procedures and new technology. It used to be as long as the procedure was a standard procedure that changing the instrumentation did not affect payment for the procedure. This has changed. Any type of new technology or new procedure is now more heavily scrutinized using evidence-based medicine.
The use of evidence-based medicine in evaluating procedures is good for physicians and their patients; however it presents significant challenges from economic standpoints as to who is responsible for financially covering new procedures which show promise. There are very high costs to doing good clinical research.
Jeffrey Wang, MD, NASS Treasurer, Professor of Orthopedic Surgery and Neurosurgery, UCLA David School of Medicine: Increasingly stringent regulations are the largest challenge to the spine industry. However, the industry should rise to the challenge. If they have a new technology, they should do the proper studies to show efficacy. If this is shown, by well-performed and appropriately designed studies, then surgeons should be able to implement this into the treatments for their patients. We should be focusing on the science and doing what works, and getting rid of things that just don't work.
We also need to ensure that the press treats the spine field fairly. I see too often that negative studies are given a heightened awareness in the press. On the other hand, when really good studies that show efficacy of spinal treatments are not even covered in the press, one starts to feel that there is some potential bias that exists in the press.
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