Why research and innovation are importantPayors are making it increasingly difficult for spine surgeons to provide the best care for their patients by denying elective procedures in non-traumatic situations. Insurance companies rely on strict guidelines, such as the Milliman Guidelines, to dictate when a procedure is "medically necessary" and will be approved for reimbursement. These guidelines may exclude patients who could benefit from surgical intervention justified by evidence-based research.
"I spend hours each week dealing with denials for generally well-accepted, evidence-based procedures," says Dr. Phillips. "The development of these guidelines for payors, typically lacks transparency, has little or no spinal specialist input and selectively use studies to approve or deny care. It becomes a runaround for patients to receive coverage. It becomes frustrating and time consuming to deal with these issues."
There have been numerous instances where Dr. Phillips hasn't been able to connect with a hard to reach case reviewer to approve the procedure until the day before the scheduled surgery, and a denial at that point is emotionally stressful and disruptive for the patient. "We see it over and over again; it's become a part of every day life for spine surgeons," he says. "It's frustrating for the physician and really devastating for the patient.
The key to ensuring coverage for necessary spine procedures lies within evidence-based medicine. "The best we can do is provide compelling data showing what we do makes a difference in patients' lives," says Dr. Phillips. "As we collect more data and that data supports the effectiveness of what we do, it will become harder for payors to deny it."
What to expect from cutting-edge research in the near futureResearch and development in spine surgery moved quickly over the past decade, but environmental forces will slow this over the next several years. Cost pressures from the healthcare system, increased regulation from the FDA and intense scrutiny on the relationship between spine surgeons and device companies will all hinder future innovation. Here are five areas of prominent spine surgery research and where they are headed in the near future:
1. Biological solutions. For the moment, spine surgeons are more hesitant to spend time researching and refining biologic solutions for spinal fusion because of the controversy surrounding rhBMP-2. Earlier this year, a group of surgeons led by Eugene Carragee, MD, a spine surgeon at Stanford University Medical Center, raised questions about the integrity of the original study data released on the only FDA-approved recombinant bone morphogenic protein product for spinal fusion, Infuse. Many of the surgeons who participated in the industry-sponsored study received compensation from Medtronic (although not necessarily related to the study), the company that produces Infuse, which Dr. Carragee and his colleagues suggest could have influenced the interpretation of outcomes data. Since then, several spine surgeons have voiced their opinions about using Infuse in their practice: some continue rigorous application while others scaled back or ceased their use.
"The field of biologics is going through a tumultuous time with the Infuse controversy, which is putting spine surgeons in an unfortunate position," says Dr. Phillips. "It seems Infuse has its place, but the negative information about the product, largely based on opinion, makes it hard to use on patients even when it may be the best solution."
As a result of this controversy, several surgeons and researchers are now looking at alternative biologics that may be able to promote fusion. "There are a lot of different molecules out there but there aren't any other products that have had as definitive results as Infuse," he says. "In the near future, we are going to see a lot of bone graft extenders, but probably not any revolutionary products in the field."
2. Stem cell use. In addition to synthetic biologic solutions, some researchers are also examining the use of stem cells for spine fusion. However, at the moment there has been little data to support or refute their effectiveness. "Although basic science studies support their effectiveness, there are few clinical studies, which we need, on the use of stem cells in spine surgery," Dr. Phillips says. "In the future, we'll see data about whether stem cells improve fusion rates and clinical outcomes.
3. Artificial disc replacement. While lumbar disc replacements have been used sparingly in recent years, cervical disc replacement seems as though it's here to stay, says Dr. Phillips. The indications for cervical spine surgery are less contentious than those in the lumbar spine, making cervical disc replacement easier to justify. Multiple FDA trials show excellent results with artificial cervical discs through at least five years..
"More payors are getting on board with artificial cervical disc replacement because it's hard to argue with the data," he says. "There will be innovation in cervical disc arthroplasty, but the regulatory process remains cumbersome. The discs that are out there now will most likely continue to show good results, but it is extremely expensive and time consuming to bring newer designs of disc replacements to the market given the regulatory hurdles. There are theoretically better artificial disc designs out there, but it will be years before we see them on the market in the United States."
At the moment, the number one most used artificial cervical disc in Germany hasn't even begun FDA trials for approval in the United States because of these issues even though the company is U.S.-based.
4. Regenerating and healing injured discs. There has been significant research in regenerating and healing damaged discs, but surgeons are still a long way from applying that research to patients. "The holy grail for spine research is regenerating and healing injured or degenerated discs," says Dr. Phillips. "Even if basic science shows a particular growth factor injection will regenerate the disc, researchers are still unsure whether that would alleviate pain in patients. There is also a question as to whether the effects of a single growth factor injection would last for an extended period of time."
5. Gene therapy. Gene therapy has been studied for disc regeneration and could offer a longer-term solution for patients because it influences disc metabolism. However, even if gene therapy is found effective, Dr. Phillips says most patients with painful disc degeneration would be unlikely candidates for the procedure given the clinical and ethical challenges with the use of gene therapy even to treat lethal conditions. "It's quite a ways away from having any mainstream clinical spinal application," he says.
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