Orthotic and Prosthetic Scope of Practice and Regulatory Status of Bone-Anchored Prostheses

Background Bone-anchored prostheses (BAPs) introduce unique challenges to the traditional scope of prosthetic care. The interdisciplinary nature of BAP provision necessitates a clear delineation of roles among healthcare providers, particularly certified prosthetists and orthotists (CPOs). This manuscript examines the scope of practice, reimbursement models, regulatory pathways, and research priorities relevant to BAP. Methods A review of current guidelines from the American Board for Certification in Orthotics, Prosthetics, and Pedorthics and Medicare coding standards was conducted. Regulatory frameworks from the U.S. Food and Drug Administration (FDA) regarding BAP implant systems were analyzed, and key research priorities were identified based on existing literature and expert consensus. Results BAP prosthetic care is within the CPO scope of practice, but requires physician oversight for certain tasks. Manufacturer-specific training and regulatory guidelines dictate appropriate maintenance and component replacement. For reimbursement, Medicare has introduced L5991 for BAP connectors, but gaps remain in coverage for full prosthetic provision, necessitating policy improvements. BAP implants are FDA Class III devices, with various access pathways including premarket approval, humanitarian device exemption, and expanded access, each impacting prosthetic care. Key areas for future investigation include patient candidacy, consultation practices, interdisciplinary team dynamics, implant system evaluations, rehabilitation strategies, long-term outcomes, and prosthetic component optimization. Conclusions The evolving landscape of BAP care requires continued refinement in practice standards, reimbursement policies, and regulatory clarity. Strengthening interdisciplinary coordination and addressing research gaps will improve patient outcomes and optimize prosthetic care following BAP surgery. Clinical Relevance Statement This article highlights the evolving role of CPOs in providing prosthetic care following BAP surgery, emphasizing the need for interdisciplinary collaboration and regulatory clarity. It addresses reimbursement challenges, regulatory pathways, and emerging research priorities that impact patient outcomes and clinical decision making. By outlining key considerations for healthcare professionals, it supports the development of standardized practices and evidence-based approaches to enhance BAP patient care.