Angela Smalley, PhD, is an Entrepreneur Fellow at TREAT. She is a recent graduate of the University at Buffalo where she received a PhD in Rehabilitation Science. Her clinical background in the field of orthotics and prosthetics offers a unique perspective for innovators interested in tackling the O&P space.
The field of orthotics and prosthetics (O&P) presents multi-level opportunities for innovation. New technologies are constantly opening up treatment possibilities and lifestyle enhancements, but it is difficult to incorporate these advances into real-life O&P practice. Entrepreneurs who want to develop orthotic and prosthetic devices need to be well-informed of the barriers to successful integration of their product idea into the complex world of O&P.
O&P clinicians are problem solvers who produce solutions for patients with complex needs. These situations require the fabrication and fitting of one-of-a-kind, custom devices. The process does not end after the initial fitting of the device, adjustments are required over time to accommodate anatomical changes or to repair wear and tear. Follow-up appointments result in new iterations of the device; straps and buckles are relocated, hinges are recalibrated, foam padding and liners are reshaped. Daily practice involves a continual process of trial and error.
This individual-level innovation is limited by a rigidly constrained reimbursement process. A complex coding structure dictates which types of O&P devices are billable to insurance companies. Each device must meet certain technical requirements that serve as landmarks for billing classification. For example, are the hinges polycentric? Is the socket double-walled? What fabrication processes were used? These considerations are key, not just for the performance of the device, but also because they determine how much can be charged. The provider must select the correct billing codes for each device, and mistakes can be costly. Incorrect billing practices have negative consequences that may range from a loss of profit to incarceration for fraud.
One source of reimbursement stress is that the availability of billing codes lags behind technological advances. For example: it is still possible to be reimbursed for a prosthesis that would not be out of place in a civil-war movie, with leather straps, metal bars and a literal wooden leg. At the same time, more modern innovations are routinely denied coverage and are determined to be “experimental or investigational” if the insurance company determines that there is insufficient evidence for its use. Because of this, some of the most exciting advances in the field, including energy returning carbon componentry, microprocessor prosthetic knees, and exoskeletons, are unavailable in reality.
Another complicating aspect of innovation within O&P is the fact that the cost of labor is supposed to be included within the billing for each new device. This includes the time of the technicians who do the fabrication work and the time of the clinician who fits the device to the patient. Therefore, the problem-solving, fitting time, and subsequent trial and error must be considered during the initial billing process. The use of new and untried technology is particularly risky if there is a chance that it will increase the amount of labor or number of office visits.
These factors combine to create barriers for innovators who have ideas for a disruptive technology within the ecosystem of O&P. Devices that do not fit within the established billing system might be unrealistic for regular practice. Although individual clinicians may be open to change and willing to experiment, there is limited flexibility available within the larger system. These restrictions are continually being tested as the rate of innovation outpaces reimbursement policy changes.
Image credit: Scout Bassett: Challenged Athlete Foundation http://caf.globotek.net/athletes/scout-bassett-2/
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