Both off the shelf and custom fit devices are considered prefabricated. But what matters most to Medicare is what you did as a qualified health provider, at the time of delivery.
If you did something a lay person could do then the device is not custom fit.If the device was prefabricated but rendered “custom” to some degree by the lab, that’s not enough. You must do something more, to make it qualify under Medicare’s rules as custom fit.
Medicare provides examples such as did you bend, mold, heat, or grind the device so as to make it fit uniquely fit the patient.Another example is if you took some prefabricated components and installed them onto the device in order to make the device fully functional.One example are for external AFO’s which attach to the shoe.They must have a special clip attached to the shoe in a specific place and in a certain manner. The clip may need to be bent and then secured to the shoe. Often times a heat gun to bend and/or widen the heel area of the brace to ensure a proper fit onto the shoe may be required.
These all go beyond the Medicare rule of "Limited Self Adjustment. This rule basically applies to modifications which any layperson can do. Adjusting a strap is one example.
To summarize: What you did as a qualified health care professional in your office at the time of delivery is what must be documented. This is necessary to differentiate your customization steps from those of “Limited Self Adjustment”Unfortunately, Medicare likley will not recognize what the laboratory did as sufficient even if they acted as your proxy, because it was not done at the time of delivery.
I recently sent an order to a lab with patient measurements. Their staff assembled the device from a kit to the measurements I provided. They then sent me the fully assembled device. Does this qualify the device as custom fit? If not, what must I do and document to qualify this device as custom fit? - WoodsideDR
Great question.
Both off the shelf and custom fit devices are considered prefabricated. But what matters most to Medicare is what you did as a qualified health provider, at the time of delivery.
If you did something a lay person could do then the device is not custom fit.If the device was prefabricated but rendered “custom” to some degree by the lab, that’s not enough. You must do something more, to make it qualify under Medicare’s rules as custom fit.
Medicare provides examples such as did you bend, mold, heat, or grind the device so as to make it fit uniquely fit the patient.Another example is if you took some prefabricated components and installed them onto the device in order to make the device fully functional.One example are for external AFO’s which attach to the shoe.They must have a special clip attached to the shoe in a specific place and in a certain manner. The clip may need to be bent and then secured to the shoe. Often times a heat gun to bend and/or widen the heel area of the brace to ensure a proper fit onto the shoe may be required.
These all go beyond the Medicare rule of "Limited Self Adjustment. This rule basically applies to modifications which any layperson can do. Adjusting a strap is one example.
To summarize: What you did as a qualified health care professional in your office at the time of delivery is what must be documented. This is necessary to differentiate your customization steps from those of “Limited Self Adjustment”Unfortunately, Medicare likley will not recognize what the laboratory did as sufficient even if they acted as your proxy, because it was not done at the time of delivery.
I recently sent an order to a lab with patient measurements. Their staff assembled the device from a kit to the measurements I provided. They then sent me the fully assembled device. Does this qualify the device as custom fit? If not, what must I do and document to qualify this device as custom fit? - WoodsideDR