The healthcare landscape has changed drastically over the past decade, especially since the passage of the Patient Protection and Affordable Care Act seeking to increase quality while lowering the cost of healthcare in the United States. Here, Steven Garfin, MD, chairman of the department of orthopedic surgery at UC San Diego and president of the International Society for the Advancement of Spine Surgery, discusses the biggest challenges for spine surgeons and where the field is headed in the future.Q: What do you consider the most important issues facing spine surgeons today?
Dr. Steven Garfin: To me, the three most important issues facing spine surgeons today are: patient access to care, new technology development and understanding axial pains.
For patient access, it's getting harder and harder to bring patients in the door and not only do what we think is right, but particularly what the literature (not just one "so called" RCT of indeterminate value and science) supports. Insurance companies, government agencies and other organizations are looking at randomized controlled trials as the be-all, end-all in science for their guidelines. Although retrospective articles, prospective cohort studies, meta analyses, etc., aren't quite at the level of evidence of randomized control trials, they still are very valuable. There are some randomized controlled trials that are done poorly, but still seem to trump all other articles with contrasting results.
The number two issue is the downward pressure for new technologies, making it hard to pass them through the FDA, and then get insurance approved once cleared by the FDA. My experience has been with the FDA system in the United States, but the same issues are coming in Europe and Asia. It's extremely, almost prohibitively, costly to gain clearance through the FDA, and then you don't even know if insurance companies will cover it. (How did they gain that power?) A lot of new ideas are stifled because we can't afford to develop them, and worse, the decisions on whether they can be used (funded) after approval are based on cost, not science. That's a problem — as we want to keep the spine field moving forward and advancing opportunities for patient care.
The third point is more on a patient-level; we need to work on our understanding of axial pains like low back and neck pain, and work on defining common words/pathologies to diagnostically describe this pain. We also need to use newer, perhaps not yet on the market, diagnostic tools, to help us develop more targeted treatment for complaints of low back and neck pain. We do a good job defining and understanding the natural history and treatment outcomes related to herniated discs and spinal stenosis, but we don't do such a good job semantically or diagnostically with the more axial, difficult-to-define, pains. Our lexicon for low back pain includes low back pain, degenerative disc disease, facet arthritis, osteoarthritis, strain/sprain, etc. — we have a bunch of words to describe back pain, but our diagnostic/pathologic criteria aren't good enough to uniquely define them. We have to be able to do that to move forward in recommending treatments. Diagnostic tools (imaging, functional, biochemical markers, etc.) need to be developed that objectively assess the source of pain.
Q: What is the role of ISASS in working with spine surgeons to successfully meet and overcome these issues?
SG: For now, I think our role is first education, then advocacy. Hopefully we can provide surgeons with the newest data and information available. We have international meetings which are helpful to share opinions, oversight and experience with people from around the world. We can also look at the evidence and science on an international basis, which is helpful because some of the "rules" for using or trying new devices outside of the U.S. are less rigid than in the United States. There is a different level of experience out there that can be shared at an individual and academic society level, which isn't at the individual country (American, German, Japanese, etc.) based level and societies. ISASS is able to provide a forum for education and science to help address patient-related issues that surgeons face all the time.
We're also focused on the spine surgeon and surgical treatment for patients. That makes the ISASS meetings, by nature, smaller and perhaps more cohesive as a forum than broad-based orthopedic, neurosurgical, or multi-specialist spine groups that cover all operative and non-operative treatments.
Q: How is ISASS responding to challenges with patient access to care?
SG: Since we are a smaller organization, we have to target what we are doing. We are responding on a case by case (state by state, region by region, etc.) basis to insurance company challenges to patient access. Unfortunately, insurance company guidelines vary from state to state, and you don't know what is coming until the guideline updates are presented. It would be great if there was a way we could be preemptive. In the future we would like to work with insurance companies to help define and write the guidelines.
Most insurance companies use the Milliman and Robertson report for guidelines, which apparently were prepared by non-spine surgeons and non-physicians. They wrote guidelines that are not evidence based, and may cite dated studies that are 10 or more years old. We would like to be available and get involved in those discussions before decisions are made about coverage for patient care. I would like us to be able to work more cohesively with other surgeon-based societies such as the American Academy of Orthopaedic Surgeons, the American Association of Neurological Surgeons and spine specialty-based societies so we are all advocating and working toward the same processes.
Q: How does ISASS handle advocacy efforts internationally?
SG: It's important for us to advocate for what the science shows, not just our own individual feeling/biases. You have to be able to address those issues on multiple fronts; not just educating surgeons, but also educating those who authorize our care recommendations for patients. Since we're international, the direction of advocacy could vary depending on where the President is based. However, over the years, clinical care and research has become more universal and what affects surgeons in the United States also becomes an issue in Europe, Asia and all other continents. Advocacy within the United States has been a strong theme for ISASS.
Q What are your goals for the society over the next year and beyond?
SG: ISASS must continue to grow and attract more surgeons and scientists who not only study devices and techniques, but also surgical outcomes. We want to help develop and promote registries to assess what spine surgeons are doing. I would like us to be the "go-to" society for spine surgeons around the world, not just for education, but also promoting patient education and access to care. I am following some strong predecessors and I hope I will be followed by strong presidents with the same intent: to evolve as an academic surgical society and create a nurturing environment for surgeons, clinicians, scientists, patients and industry that highlights the value spine surgery can bring to patients.
Q: Where do you see the biggest opportunities in spine care over the next decade?
SG: The biggest opportunities are tied to technology and procedure development. We don't think ISASS, or any academic society, should be the judge and jury of every new device. If the FDA approves something, we think ongoing outcomes assessments and the market place should decide what is good or bad. The FDA sets standards and tests, and medical device companies pay for the trials. If it is cleared by the FDA and allowed to go forward, I think it should go forward. If we follow that prescription, we will be a group that can nurture this process.
Working collegially with industry, academicians and private practice spine surgeons will help us move forward. If we bring them all together at the same table and have a fair conversation, we can overcome some of the challenges we face today. We should also be at the table with insurance companies and organizations writing guidelines to come up with new ideas, guidelines and policies, that won't bankrupt companies trying to bring products to the market. If the product improves patient care, it should be covered and paid for. That may mean older or scientifically non-validated procedures do not get funding. Decisions in healthcare can't be just driven by cost.
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