The following are not covered: Services for which the medical laboratory provider cannot supply a properly completed order or standing order identifying the individual practitioner who ordered the laboratory services; Services not adequately documented in the participant’s medical records; Services denied by Medicare as not medically necessary; Clinical laboratory services, for which certification by HCFA under CLIA is required, when these services are performed by laboratories that are not certified to perform those services; Procedures that the provider knows or should know are investigational or experimental in nature; Services included by the Program as part of the charge made by an inpatient facility, hospital outpatient department, freestanding clinic, or other Program-recognized entity; Medical laboratory services related to autopsies; Medical laboratory services for which there was insufficient quantity of specimen, improper specimen handling, or other circumstances that would render the results unreliable; and Laboratory services ordered by an: Individual who is not enrolled as a provider in the Program with an active status on the date of service; and Entity, facility, or another provider that is not an individual.