Objectives: This article establishes needed guidelines for determining orthotic prescriber authority, documenting medical necessity, and ensuring continuity of care for patients needing orthoses. It also identifies “off-the-shelf” (OTS) devices that can safely and appropriately be delivered to patients without professional adjustment as well as those that cannot. Methods: A multidisciplinary task force made up of experts in orthopedics and physical medicine physicians, along with therapists and certified orthotists, applied a consensus approach to answer key questions: (i) When can a device be safely, effectively delivered to the patient OTS without professional guidance or education, and which caregivers have a role in that decision? (ii) What documentation is appropriate for physicians and other caregivers to determine medical necessity? (iii) What documentation/communication ensures continuity of care among physicians, therapists, and orthotists? Results: Guidelines developed for consideration of OTS orthoses include accepting documentation from collaborating caregivers, including therapists and orthotists; keeping that documentation as part of the patient’s total medical record for clinical, medical necessity determinations and reimbursement purposes; and using the physician’s prescription for the device as the key determinant of whether a device is delivered OTS or as a custom-fitted device. Conclusion: This review provides expert guidance for patient safety, minimizing wasted expenditures, maximizing clinical outcomes, and providing efficient delivery of care for Medicare and other patients. Centers for Medicare and Medicaid Services guidelines should be directed toward recognizing the level of expertise of the orthotist, the value of their patient encounters, and their role in facilitating the timely, safe, and effective use of orthotic devices.
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