Journal of NeuroEngineering and Rehabilitation

Background Orthotic and lower extremity prosthetic devices and related clinical services are designed to provide pa- tients with stability and mobility. While the literature contains considerable evidence of geographic vari- ation in both major amputation rates and the use of orthotic and prosthetic (O&P) services [ 1 – 3 ] , there are limited studies of the extent to which beneficiar- ies who receive O&P services experience a reduction in complications and/or costs with favorable outcomes [ 4 ] . While the variability in measures of quality and pa- tient outcomes in research on O&P services can make comparisons difficult, studies have shown that the provision of O&P services led to measurable improve- ments in the quality of patient care and functional and psychosocial outcomes [ 5 – 7 ] . Beyond physical health, receipt of O&P services is associated with im- proved mental health status, in terms of social func- tioning, general health perception, and role limitation due to emotional problems [ 8 ] . The receipt of O&P services may also lead to societal gains including the return to work [ 9 ] . Additionally, O&P services can reduce health care spending via better patient outcomes, which in turn reduce other types of health care utilization [ 10 , 11 ] . Long-term savings are thought to result when patients receive appropriate orthotic and prosthetic care. Without such care, individuals may live more seden- tary lifestyles, which research has shown leads to sec- ondary complications, such as diabetes and related comorbidities, as well as increases in health care utilization and spending [ 12 ] . Additionally, in some cases, the use of more sophisticated technology has been found to increase the quality of care and patient outcomes [ 13 ] . The beneficiary ’ s quality of life may very well be improved as well through increased mobility [ 14 ] . Our prior custom cohort study of orthotic and prosthetic Medicare beneficiaries that was based on Medicare claims experience over the 2007 – 2010 period found that the study group of patients who received timely orthotic or prosthetic care had lower total health care costs than a comparison group of untreated patients [ 10 ] . This study reports on a paral- lel analysis based on Medicare claims from 2011 to 2014 and includes Part D in addition to Parts A and B. Its primary objective is to validate earlier conclu- sions on the extent to which Medicare patients who received select orthotic and prosthetic services had less total health care utilization, lower Medicare payments, and/or fewer negative outcomes compared to matched patients not receiving these services. While the data are from Medicare only, the results of this study can inform the value proposition of orthotics and prosthetics for other payers. Methods A retrospective cohort design of 78,707 one-to-one matched pairs of Medicare constituents ( N = 157,414) was utilized. From an economic design type, a cost-consequence evaluation design was used with a total four-year time horizon. The payer ’ s perspective was selected for study to gain an understanding of value as it relates to orthotic and prosthetic provision under the Medicare program as a primary member of the reim- bursement community. Study procedures were adminis- tered in accordance with the Declaration of Helsinki. This study focuses on three types of O&P services – lower extremity orthoses, spinal orthoses, and lower extremity prostheses. The analytic methodology con- sisted of three key activities, including: 1) developing patient cohorts of orthotic and prosthetic users and matched comparison groups using a propensity score approach; 2) developing clinical episodes of care for each individual beneficiary; and 3) calculating descrip- tive statistics and analyzing the impact associated with each O&P service on Medicare episode utilization and payments. Developing patient cohorts Analyses were conducted using Medicare claims from a custom database provided by the Centers for Medi- care & Medicaid Services (CMS) (Data Use Agree- ment No. 28710). We requested a sample of beneficiaries with claims from 2011 to 2014 for patients with specified etiological diagnoses who re- ceived select lower extremity orthotic, spinal orthotic, or lower extremity prosthetic services. The etiological diagnosis related to the condition which ultimately led to the need for the lower extremity orthotic, spinal orthotic, or lower extremity prosthetic service (e.g., a functional diagnosis for a prosthetic device), not the diagnosis linked to the claims at the time of receipt of the service. 1 These beneficiaries represented the study group population for each O&P service. CMS identified the comparison (i.e., control) group population by matching beneficiaries to the patients who received orthotic and/or prosthetic devices (study group) based on the presence of an etiological diag- nosis, gender, age, and state of residence. CMS pro- vided up to five comparison group patients, who did not receive the select O&P services of interest, pre- liminarily matched to each study group patient. The sampling methodology utilized by CMS to extract the custom cohorts allowed the analyses to reflect those Medicare beneficiaries who received an appropriate etiological diagnosis after January 1, 2011. Dobson et al. Journal of NeuroEngineering and Rehabilitation 2018, 15 (Suppl 1):55 Page 62 of 72