Reasonable and Necessary Provisions in LCDs

13.5.4 – Reasonable and Necessary Provisions in LCDs (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) An item or service may be covered by a contractor LCD if: • It is reasonable and necessary under 1862(a)(1)(A) of The Act. Only reasonable and necessary provisions are considered part of the LCD. Reasonable and Necessary Contractors shall determine and describe in the LCD the circumstances under which the item or service is reasonable and necessary under 1862(a)(1)(A). Contractors shall determine if evidence exist to consider an item or service to be reasonable and necessary if the contractor determines that the service is: • Safe and effective; • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary); and • Appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is: o Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member; o Furnished in a setting appropriate to the patient's medical needs and condition; o Ordered and furnished by qualified personnel; o One that meets, but does not exceed, the patient's medical need; and o At least as beneficial as an existing and available medically appropriate alternative.