Clinical Laboratory Improvement Amendments Requirements Notice

Attention Community First Health Plans Providers

This notice is intended to ensure that you are reimbursed based on the code or codes that correctly describe the health care services provided.

You are responsible for the submission of accurate claims.

Community First Health Plans reimbursement policies may use Current Procedural Terminology (CPT®*), Centers for Medicare and Medicaid Services (CMS), or other coding guidelines. References to CPT or other sources are for definitional purposes only and do not imply any right to reimbursement.

This notice applies to all health care services billed on CMS 1500 forms and, when specified, to those billed on UB04 forms. Coding methodology, industry-standard reimbursement logic, regulatory requirements, benefits design, and other factors are considered in developing Provider reimbursement.

This information serves as a general reference resource regarding Community First Health Plans reimbursement for the services described and is not intended to address every aspect of a reimbursement situation.

Diagnostic testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of Clinical Laboratory Improvement Amendments certificates based on the kinds of diagnostic tests they conduct.

Clinical Laboratory Improvement Amendments requires all facilities that perform even one test, including waived tests, on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet certain Federal requirements. If a facility performs tests for these purposes, it is considered a laboratory under Clinical Laboratory Improvement Amendments and must apply and obtain a certificate from the Clinical Laboratory Improvement Amendments program that corresponds to the complexity of tests performed.

A certificate of waiver allows a laboratory to perform only tests categorized as waived.
A certificate of PPM allows a laboratory to perform tests categorized as provider perform microscopy procedures and if desired, waived tests.
A certificate of compliance allows a laboratory to perform tests categorized as waived, PPM, moderate, or high complexity.
A certificate of accreditation allows a laboratory to perform tests categorized as waived, PPM, moderate, or high complexity.

Both Medicaid and Medicare require facilities that bill laboratory testing to be Clinical Laboratory Improvement Amendments certified. When denials are received, you should first check that you have submitted the correct Clinical Laboratory Improvement Amendments certificate(s) to Community First Health Plans. You should next verify that you are submitting the correct CPT code or determine if the CPT code requires a QW modifier.

The Community First Health Plans claim processing system will verify that you have a valid Clinical Laboratory Improvement Amendments certificate and that the testing you are performing is allowed under your certification type. Codes outside of your Clinical Laboratory Improvement Amendments certification type will be denied.

To help ensure your claims are processed quickly and accurately, please follow the guidelines listed below:

For paper claims submitted on the CMS 1500, enter the 10-digit Clinical Laboratory Improvement Amendments ID in field 23.
For 837 professional electronic claim submissions, enter your 10-digit Clinical Laboratory Improvement Amendments ID number in Loop ID 2300 segment/data element REF02, where REF01 = X4.
The Clinical Laboratory Improvement Amendments number entered must be specific to the location where the provider is performing on-site lab testing.
Claim payments can only be made for dates of service falling within the particular certification dates governing those services.
Providers are reminded to add the QW modifier to the procedure code for Clinical Laboratory Improvement Amendments waived tests when required.

You can refer to your Clinical Laboratory Improvement Amendments Certificate to obtain the laboratory certification codes licensed to your facility.

References:

https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/lccodes.pdf

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA

https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/howobtaincliacertificate.pdf