Furthermore, payment of claims in the past (based on stacking codes) or in the future (based on the new code series) is not a statement of coverage since the service may not have been audited for compliance with program requirements and documentation supporting the reasonable and necessary testing for the beneficiary. Many applications of the molecular pathology procedures are not covered services given lack of benefit category (e.g., preventive service or screening for a genetic abnormality in the absence of a suspicion of disease) and/or failure to the reasonable and necessary threshold for coverage (e.g., based on quality of clinical evidence and strength of recommendation or when the results would not reasonably be used in the management of a beneficiary). For laboratory services, a service may be reasonable and necessary if the service is safe and effective and appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis of the patient's condition furnished in a setting appropriate to the patient's medical needs and condition ordered and furnished by qualified personnel one that meets, but does not exceed, the patient's medical need and is at least as beneficial as an existing and available medically appropriate alternative. This Local Coverage Determination (LCD) addresses the circumstances under which the item or service may be reasonable and necessary.
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