In preparation for NASS, we spoke with Executive Director and CEO Eric Muehlbauer and Christopher M. Bono, M.D., President of the North American Spine Society, to identify areas in which the group has made recent progress, challenges that remain and where room for new technologies exists. Both discussed reimbursement matters—a concern for those who use the implants and those who build them. What else was on the President’s mind?
BONEZONE: In a survey that we conducted in conjunction with NASS in 2015, surgeons responded that reimbursement concerns and insufficient outcomes data/evidence were their two greatest barriers to new technology adoption. What activity do you anticipate on these fronts in the next two to three years, that you expect will continue for the foreseeable future?
Bono: These concerns continued in 2016. NASS has made substantial progress, however, particularly in the area of reimbursement. NASS’ Coverage Policy Recommendations, which are available as a searchable eBook, are increasingly utilized by major insurance providers in developing their own coverage policies.
Furthermore, NASS has developed strong relationships via in-person meetings with most of the major carriers in the U.S., including CMS. Thus, we feel that we have made great progress in the ability to effect real change in current reimbursement of spinal procedures.
As an example, a recently introduced minimally invasive procedure had been previously not covered by insurance companies, and was deemed “investigational.” The manufacturer sponsored a number of studies, including a large pivotal, randomized controlled trial. With these data, NASS was able to develop a sound and rational coverage recommendation with appropriate, yet strict, criteria which have been adopted by some insurers, seemingly verbatim. We view this as a real victory. (Of course, this is not to say that there is not much work yet to be done, which our volunteers and staff continue.)
BONEZONE: Could other barriers arise and replace reimbursement and outcomes data, from the surgeon’s view?
Bono: This is an interesting question. While right now insurance companies have control over the volume of spinal procedures via coverage criteria and reimbursement, which is (at least in theory) supposed to be determined largely by the available evidence, the age of bundled payment episodes is looming.
In this scenario, the insurance company, whether private or government-supported, will have little interest in the specific indications for surgery, the timing of procedures or the choices made by practitioners or patients. They will be interested only in the patient “getting better” from whatever treatment is delivered. The healthcare delivery center will, by nature, be forced to determine and deliver the most efficient and high-value care. Such a system places greater emphasis on the ability to predict individual patient outcomes rather than population-based outcomes of a procedure for a disorder.
BONEZONE: You’ve led NASS activities in coverage recommendations and evidence-based clinical guidelines. Reimbursement and building clinical evidence can be two difficult initiatives for device companies, as well. In what ways can surgeons and industry work together on these?
Bono: This has a very easy answer: communicate. There should be strong communication between an organization like NASS and industry in order to ensure that study designs and the evidence produced will be of the quality standard needed in order to make sound coverage recommendations. This has already begun to happen.
When we spoke to Muehlbauer, he said that companies neglect to develop a reimbursement strategy alongside their device approval strategy. FDA might want you to prove safety and effectiveness, but insurance companies work by the standard of reasonable and necessary. Device companies can and must play a role in evidence generation to positively impact reimbursement; one way to do that is to be published in the literature.
BONEZONE: As a surgeon who practices nearly every facet of spinal surgery, where do you see technological gaps?
Bono: The technological gaps I see are not in the “nuts and bolts” of surgery, but rather in biologics, complication prevention and risk stratification. In the field of biologics, there are still opportunities to do a better job of enhancing spinal fusion with materials that are more physiologic.
As for complication prevention, we are beginning to scratch the surface with use of antibiotic powder in patients at high risk for wound infection. There are likely to be better delivery mechanisms for local antibiosis in the future.
As for risk stratification, this is the area that I think will be most impactful. Such an endeavor will exploit large outcomes databases, such as the NASS registry, in order to develop patient-specific risk and outcome profiles. These can be used to determine the best candidates for a specific procedure and what unique risks a patient has for adverse events.
BONEZONE: What one thing would you like to share with device company professionals?
Bono: The well-being of the patients our members treat depends upon our ability to communicate and collaborate with many stakeholders, including device companies. NASS truly wants to hear feedback and work with device companies and others to ensure that patients are receiving the very best care.
Christopher Bono, M.D, is an orthopaedic surgeon and Chief of Spine Service at Boston’s Brigham and Women’s Hospital, as well as an Associate Professor of Orthopedic Surgery at Harvard Medical School. Bono has been a member of NASS since 2003 and was named NASS President during the Society’s 30th Annual Meeting in 2015.