An approximate number of 1.6 million represented the number or persons living with a limb loss in the United States in the year 2005.  Forty percent of these individuals underwent a major amputation of lower extremity.  It is projected that the number of amputees will more than double by the year 2050. Limb prosthetics constitutes a part of Durable Medical Equipment (DME) expenditures, which is most expensive for a payer source. Medicare-approved rates for a single prosthesis may range between $4,000 and $40,000. Medicare Functional Classification Level (MFCL) system was created to describe five levels of functional ability and in turn designate the appropriate prosthetic componentry for each class level. The MFCL index has a range from a fully dependent bed-bound individual (K-0) to a recreational athlete capable of higher-level activities (K-4). Although the definitions clearly describe observable differences between each of the five levels using commonly assessed functional skills, the actual designation of functional levels is performed very subjectively by either the provider of the services or the prescribing physician. The additional cost of componentry, associated with K-3 functional category or higher may very easily double or triple the total cost of the device.

         Bio-Analytic Research, LLC offers a set diagnostic procedures that would objectively determine patient’s functional level based on the criteria set forth by MFCL system. The outcome of the diagnostic tests may easily be documented and, together with the conclusion, submitted to the payer source for the final determination.