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AOPA Statement on 3-D Printing in Prosthetics and Frequent Errant Estimates of the Average Cost of Upper and Lower Limb Custom-Fabricated Prosthetic Devices

Posted on by Lauren Anderson

America’s prosthetic and orthotic health professionals deliver patient – centered care each day to persons of all ages whose mobility has been compromised by limb loss and chronic limb impairment. This includes the commitment for trained, licensed and accredited health professionals delivering cost efficient care that also meets all patient protections established via federal and state statutes and rules, utilizing devices that satisfy all FDA requirements. We are intrigued by the emerging 3-D technologies outlined in several recent TV, print and Web-based media reports, while noting that in many cases the care featured involves instances that do not fully comply with FDA rules and/or federal or state licensure and accreditation requirements. We must also underscore that these reports frequently include serious inaccuracies in characterizing current costs of federally compliant advanced upper extremity prosthetics as between $40,000 and $80,000, when actual costs are often only about one-twentieth of those amounts ($1,500 to $5,000). All who share a true commitment to quality care would strongly encourage media involved in preparing and fact-checking such reports to be cognizant of these rampant inaccuracies, even as we all watch with great interest how new and promising patient treatment options may be evolving.

Information Technology Leaders Hail to Cutting Edge Advances and Improved Patient Outcomes of Today’s Prosthetic Devices (Super Bowl Ad, 2/1/2015).

New analysis from Dobson DaVanzo: 19{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368} of patients with a Medicare-reimbursed Off the Shelf orthotic device later receive a custom-fitted or custom-fabricated device

Posted on by Mobility Saves
Type Total Patients Received OTS as First Orthotic Device Subsequently Received Custom Fitted/Fabricated Device
Patients Percent of Total Patients Patients Percent of OTS Patients
TLSOs 20,408 1,519 7.4{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368} 163 10.7{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368}
LSOs 197,906 19,917 10.1{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368} 3,372 16.9{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368}
AFOs 268,232 56,959 21.2{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368} 11,359 19.9{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368}
Total 486,546 78,395 16.1{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368} 14,894 19.0{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368}

Source: Dobson-DaVanzo analysis of custom cohort Standard Analytic Files (2007-2010) for Medicare beneficiaries who received O&P services from January 1, 2008 through December 31, 2008.

Medicare’s own data shows that frequently patients who receive a Medicare-reimbursed OTS device subsequently also receive a Medicare-reimbursed custom-fitted or custom-fabricated orthotic device. Clearly, some modest portion of these data reflect instances in which OTS devices are fitted out of necessity in the acute or emergent setting and occasionally with the knowledge that a custom-fitted or custom-fabricated orthotic device  will be required further down the road. There are also instances with progressive disorders where an OTS device may be sufficient for a period of time before their condition warrants a custom-fitted or custom-fabricated orthotic device . Clinical experience indicates that such instances could account for a relatively small portion of the 19{cd9c44e368fb6cee2d09ae9816b0d094fbe47d90389af7031507558183226368}. But it also appears likely that there is a very significant percentage of cases where OTS devices do not fully or appropriately meet the patients’ needs.

It appears that delivering substantial numbers of OTS devices without any accompanying adjustment and clinical care may not result in patients getting better, but results, at least in a substantial number of instances, in wasted Medicare funds on that OTS device AND a delay in the patient receiving any improvement in their symptoms/ health. In this unfortunate reality, both the patient and the Medicare program will be negatively impacted as a result of increase patient co-payments and additional expenses to the Medicare program, and a disregard for patient health for Medicare beneficiaries as a result of CMS mandating that devices be provided to patients without professional adjustment and fitting, contrary to the premises for FDA-approved labeling.