Evidence of Medical Necessity

5.11 - Evidence of Medical Necessity (Rev. 10538; Issued: 12-30-20; Effective: 01-01-20; Implementation: 12-29-20) If replacement supplies are needed for the therapeutic use of purchased DMEPOS, the treating practitioner must specify on the standard written order, or on the CMN, the type of supplies needed, in such a manner that the supplier may calculate the necessary disbursement and assess the continued need for refill with the beneficiary. DME MACs, UPICs, and other contractors evaluate supply utilization information as part of their medical necessity and coverage determinations for DMEPOS. Absent a State law to the contrary or a supply utilization problem, the standard written order or CMN submitted for the DMEPOS may also serve as medical evidence for supply replacement claims. However, when a standard written order for DMEPOS is renewed or revised, supply utilization information must be specified or updated by the treating practitioner on the CMN. DME MACs, UPICs, and other contractors assess the continuing medical necessity. The DME MACs, UPICs, and other contractors must establish procedures for monitoring the utilization of replacement supplies. Suppliers must have documentation to support the medical necessity of changes in the equipment, device, or supply utilization requirements. Absent such notification, DME MACs, UPICs, and other contractors do not allow claims for unexplained increases in supply utilization above the usage level they previously determined as medically necessary. Suppliers shall make this information available to the DME MACs, UPICs, and other contractors on request. If necessary or appropriate for a medical necessity determination, the DME MAC, UPIC, or other contractor must ask the supplier to obtain documentation from the treating practitioner, establishing the severity of the patient's condition and the immediate and long term need for the equipment and the therapeutic benefits the patient is expected to realize from its use. A claim of therapeutic effectiveness or benefit based on speculation or theory alone cannot be accepted. When restoration of function is cited as a reason for use of DMEPOS, the exact nature of the deformity or medical problem should be clear from the medical evidence submitted. Also, the manner in which the equipment or device will restore or improve the bodily function should be explained by the treating practitioner. If the DME MAC, UPIC, or other contractor is unsuccessful in obtaining medical information from the supplier for non-assigned claims, it gives the beneficiary the opportunity to obtain the desired information from the supplier. If, after obtaining the requested information, a question of medical necessity remains, the DME MAC, UPIC, or other contractor must resolve the issue.