Laboratory - JE Part B

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
• Incorrect Laboratory Services Billing Identified by MR and CERT
• International Normalized Ratio Home Monitoring
• Laboratories Billing for Referred Tests
• Laboratory Orders Must be Submitted Within 12 Months of Order
• Physician Impact on Laboratory Service Providers
• Physician's Orders for Diagnostic Laboratory Tests
• Related Latest Updates Articles
• Resources
• Screening and Diagnostic Services
• Screening Services
• Specimen Collection and Travel Allowance Fees

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

For more information on how to enroll, visit the CLIA Enrollment webpage.

Laboratories Billing for Referred Tests

Section 1833(h)(5)(A) of the Act indicates that a referring laboratory may bill for clinical laboratory diagnostic tests on the clinical laboratory fee schedule when Medicare beneficiaries are provided services by a reference laboratory only if the referring laboratory meets certain conditions.

To ensure a Medicare Administrative Contractor (MAC), Noridian, adds the appropriate edit allowing for the proper billing method and payment, a referring laboratory must attest to which option applies to their billing scenario prior to billing services.

A Laboratories Billing for Referred Tests - Self Attestation is available for provider completion.

• Complete form and fax or mail it to Noridian Provider Enrollment team for review

Note: Authorized or Delegated Official on file for enrollment file must sign and date (handwritten signature) the form

Resources

• CMS CLIA Overview
• 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 Change Request (CR) 6018 - Date of Service (DOS) for Clinical Laboratory and Pathology Specimens
• CMS CR8339 - Coding Requirements for Laboratory Specimen Collection Update
• CMS National Coverage Determinations for Laboratory Services