Policy and Ethical Considerations for Widespread Utilization of Generic Orthopedic Implants.

Abstract

In 2015, the United States spent $3.2 trillion on healthcare, representing 18% of the nation’s gross domestic product [1]. As prices continue to climb, physicians, healthcare policymakers, and industry leaders alike have sought varied means to lower costs while maintaining the quality of care. Coverage expansion, shifts toward bundled care payments, and the implementation of Medicare Payment Reform (Medicare Access and Children’s Health Insurance Program Reauthorization Act of 2015 [MACRA]) are indicative of shifting dynamics in the American healthcare system prioritizing outcomes, value, and cost-containment over the fee-for-service model [2], [3]. Orthopedic implant expenditures are considerable in the overall cost of care for surgical patients. The cost of total joint arthroplasty implants between 1996 and 2006 increased an estimated 130%. Implant and medical device costs comprise up to 60% of hospital reimbursements for primary procedures [4]. Most implants are proprietary in nature and vary substantially in their price and features depending on the industry manufacturer [5], [6], [7]. Control of implant costs is thus a necessary focus for cost containment in orthopedic surgery. To that end, as patents on many brand name implants begin to expire, “generic” implants present a unique opportunity to improve the value of orthopedic care. Although generic drugs have been used for decades in the pharmaceutical industry, the use of generic implants has only recently been considered in the field of orthopedic surgery [8], [9], [10]. In the pharmaceutical sector, an estimated $33 billion has been saved by Medicare in the United States through utilization of generic medications [11]. There could be potential for an analogous substantial reduction in healthcare expenditures via the use of generic orthopedic implants. There is some literature describing the favorable economic possibilities for use of generic orthopedic implants [9], [10], [12]. However, the ethical issues, policy implications, and potential unanticipated consequences of such a paradigm shift have not been investigated. This article discusses the pros and cons of generic implant usage from economic, clinical, and ethical perspectives.