Noridian processes lab services based on the CMS established regulations.
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.
Access the below lab related information from this page.
- Clinical Laboratory Improvement Amendments (CLIA)
- Home PT/INR Monitoring (G0249) Billing and Coding [PDF]
- Incorrect Laboratory Services Billing Identified by MR and CERT
- International Normalized Ratio Home Monitoring
- Physician's Orders for Diagnostic Laboratory Tests
- Related Latest Updates Articles
- Screening and Diagnostic Services
- Screening Services
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
- CMS CLIA Overview
- CMS CLIA Webpage
- CMS Clinical Labs Center
- CMS Clinical Lab Fee Schedules
- CMS Clinical Labs Center
- CMS Downloadable list of Waived and PPMP Tests
- CMS How to Obtain a CLIA Certificate
- CMS Internet Only Manual (IOM), Publication 100-04, Medicare Claims Processing Manual, Chapter 16
- CMS IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, section 80.1
- CMS Lab National Coverage Determinations (NCDs)
- CMS Medicare Learning Network (MLN) Matters (MM)8339 - Coding Requirements for Laboratory Specimen Collection Update
- CMS MM8517 - 2014 Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment Update
- CMS MM6018 - Date of Service (DOS) for Clinical Laboratory and Pathology Specimens
- CMS National Coverage Determinations for Laboratory Services
Last Updated Oct 23, 2017
The below are topic specific articles which have been published to "Latest Updates" and sent out in Noridian emails within the past two years. Exclusions to this include time sensitive related announcements such as: Noridian and CMS educational events, Ask-the-Contractor Teleconferences and claims processing downtime.