Compliance Corner

Can a high-complexity CLIA-certified laboratory perform and bill for a test marked as research use only or investigational use only by the manufacturer?

As long as the laboratory meets the CLIA validation requirements at 42 C.F.R. 493.1253, it can perform the test. That does not mean payers must pay for the test. For instance, Medicare does not pay for tests it considers not reasonable and necessary to diagnose or treat a Medicare beneficiary, according to Section 1862(a)(1) of the Social Security Act. One of the things that makes a test not reasonable and necessary is that it is considered investigational or for research use only. One reason labs get confused about this is that it is not specifically articulated anywhere except in the Medicare claims processing manual in Chapter 30, Section 40.3.6.4 and Section 50.3.1, where it says, “When Medicare considers an item or service experimental (e.g., a ‘Research Use Only’ or ‘Investigational Use Only’ laboratory test), payment for the experimental item or service is denied under §1862(a)(1) of the act as not reasonable and necessary.” Commercial or private payers may or may not pay depending on their coverage policies, and labs should check with the payer before performing the test.

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