Medicare Compliance & Reimbursement

What labs should watch for on tests that could be waived or moderate complexity. 

Labs had better not stumble on test systems that can be categorized as either waived or moderate complexity - the wrong move could leave them saddled with a Clinical Laboratory Improvement Amendments citation.

In a Nov. 13 letter to state survey agency directors (Ref: S&C-04-05), the Centers for Medicare & Medicaid Services points out that labs might not always be using the proper instructions for tests that can be considered waived or moderate complexity.

Labs with a certificate of waiver or a certificate for provider-performed microscopy need to be careful not to use the instructions that apply to moderate complexity testing. If they blunder, they risk being cited "for performing tests beyond the scope of the certificate held by the laboratory, as well as failing to follow manufacturer's instructions," CMS says.

CMS adds that the waived/moderate complexity distinction could depend on the specimen type, on QC requirements or on the analyte tested.

To see the letter, go to http://www.cms.gov/medicaid/survey-cert/sc0405.pdf.

Lesson Learned: Waived labs should make sure they use the proper instructions for tests that could be classified as either waived or moderate complexity.