CMS updates CLIA waived tests

CMS recently issued Medicare Claims Processing Manual Transmittal 1799 (CR 6570), which is a Recurring Update Notification to inform contractors of new waived tests approved by the Food and Drug Administration under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Since these tests are marketed immediately after approval, CMS must notify its contractors of the new tests so that the contractors can accurately process claims.  This seems like a good time to review the basic guidelines set out under CLIA with respect to waived tests.

CLIA regulations require that all laboratories performing and billing tests to Medicare be appropriately certified.  There are varying levels of certification under CLIA, including certificate of waiver, certificate for provider-performed microscopy procedures (PPMP), certificate of registration, certificate of compliance, and certificate of accreditation.

Only laboratories with a current certificate of waiver are permitted to bill, and receive payment from, Medicare for laboratory tests categorized as waived complexity under CLIA.  To ensure that Medicare only pays for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level.

Independent laboratories performing tests covered by CLIA must submit their CLIA number in Item 23 of the CMS 1500 paper claim (or its electronic equivalent).  The CLIA number, however, is not required on the UB-04 (or its electronic equivalent).

Using data obtained from the certification process, the Common Working File (CWF) edits Carrier/MAC claims to ascertain that the laboratory identified by the CLIA number is certified to perform the test.  Providers that bill FIs are responsible for verifying CLIA certification prior to ordering laboratory services under arrangement. The survey process validates that these providers have procedures in place to insure that laboratory services are provided by CLIA approved laboratories.

CMS identifies waived tests by providing an updated list of waived tests to Medicare contractors on a quarterly basis via a Recurring Update Notification. To be recognized as a waived test, some CLIA waived tests have unique Healthcare Common Procedure Coding System (HCPCS) procedure codes and some must have a QW modifier included with the HCPCS code.

Hospitals are encouraged to review Transmittal 1799 (CR 6570) (along with MLN Matters Article MM 6570 and Job Aid JA 6570) carefully with respect to the updated list of waived tests and related billing requirements, including attachment of -QW modifier.  Please note that your Medicare contractor will not search their files to either retract payment or retroactively pay claims processed before CR 6570 is implemented. However, they will adjust claims that you bring to their attention.