Independent clinical laboratory
This page is a central location for independent clinical laboratory information, including CMS resources.
Spotlight
CLIA information
The clinical laboratory improvement amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by CMS. Comprehensive information is available on the CLIA page on CMS.gov.
Enrolling
The following resources support enrollment activities for independent clinical laboratories:
- To enroll in Medicare, clinical laboratories must submit the CMS-855B Clinics/Group Practices and Other Suppliers application or it's equivalent in PECOS
- View tips for Completing the Medicare 855B enrollment application
- Required form: Clinical laboratories questionnaire (Referred tests attestation) must be submitted with the application
LCD / NCD – policy information
Not all codes have a policy associated with them. First Coast will consider reasonable and necessary services for payment in the absence of an LCD, billing and coding article, NCD, or CMS manual instruction that limits coverage.
LCDs
Learn more about the local coverage determination (LCD) development process through the following:
Search for clinical laboratory-related LCDs using these available resources:
- LCD interactive index tool
- View First Coast’s active / proposed LCDs on CMS’ Medicare coverage database (MCD)
NCDs
Search for clinical laboratory-related national coverage determinations (NCDs) using these available tools:
Medical documentation
For a claim to be valid, documentation must demonstrate compliance with all applicable coverage, coding and billing requirements and substantiate the level of care billed. The following resources are specific to this specialty, but may not address all required medical documentation requirements:
- Complying with documentation requirements for laboratory services
- Medicare provider compliance tips
- Targeted probe and educate review topics
- Checklist: Clinical labs
- Document and bill genetic tests correctly
Claim submission and reimbursement
- Travel allowance for collection of specimens
- New process for pathology and laboratory codes
- Potential assignment violations by clinical laboratories
- Clinical laboratory modifier 91
- Bill infectious disease panels correctly
- Clinical laboratory fee schedule
- Clinical laboratory fee schedule fact sheet
Education
- Ordering and billing drug assays for your Medicare patients YouTube
- View First Coast’s upcoming events
- View First Coast's on-demand learning
Resources
CMS
- Medicare Claims Processing Manual, Chapter 16 - Laboratory services
- Medicare Benefit Policy Manual, Chapter 15, section 80.1, Clinical Laboratory Services
- Medicare National Coverage Determinations Manual, Chapter 1, Part 3 (sections 170 – 190.34), Coverage determinations
- National Correct Coding Initiatives Edits (NCCI)
First Coast
- Model compliance plan for clinical laboratories
- View our FastTrack to Medicare coverage policies to locate guidelines
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