There has been a long-standing requirement, by Medicare and many other payers, that any custom-fabricated item must be supported by detailed clinical notes indicating the process by which the device was fabricated, and the materials used in the fabrication. This holds true even if fabrication is outsourced to a central fabricator, because in the event of a formal claim review, the supplier must be able to produce documentation from that third party supporting custom fabrication and materials.
As with many documentation policy requirements, we are seeing a trend across major payers to begin more stringent enforcement of the requirement in the form of complex claim reviews. As a result, there has been a significant increase in the frequency of claim denials and recoupments because the supplier has failed to provide the required detailed documentation.
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