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

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.