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Laboratory

Noridian processes lab services based on the CMS established regulations (provided as a resources within this webpage).

Diagnostic X-ray, laboratory, and other diagnostic tests, including materials and the services of technicians, are covered under the Medicare program. Some clinical laboratory procedures or tests require Food and Drug Administration (FDA) approval before coverage is provided.

  • A diagnostic laboratory test is considered a laboratory service for billing purposes, regardless of whether it is performed in:
  • A physician's office, by an independent laboratory;
  • By a hospital laboratory for its outpatients or nonpatients;
  • In a rural health clinic; or
  • In an HMO or Health Care Prepayment Plan (HCPP) for a patient who is not a member.

Clinical Laboratory Improvement Amendments (CLIA)

CMS regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, The objective of the CLIA program is to ensure quality laboratory testing. CMS has resources available that address the guidance and coordination and quality control of CLIA as well as:

  • State Agency or Regional Office CLIA contacts
  • Direct Access Testing (DAT)
  • Office of Inspector General (OIG) reports
  • Micro sample pipetting information for laboratories
  • Identifying Best Practices in Laboratory Medicine - a Battelle Project for the Centers for Disease Control and Prevention (CDC)
  • FDA Safety Tip for laboratories on how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices

CLIA specific resources include:

Resources

Last Updated Oct 24, 2016