On January 15th, CMS released the list of new and discontinued codes subject to CLIA edits in calendar year 2016. The notification includes a list of 43 discontinued lab test codes and 37 newly established codes. The 37 new codes include drug testing codes, genetic analysis codes, codes for blood tests for obstetrics, and codes describing tests utilizing multianalyte algorithmic analysis. Each of the newly established codes requires a provider to have a CLIA certificate of registration, compliance or accreditation in order to be paid. Facilities without one of these three valid certificates or with a certificate of waiver or a certificate for provider performed microscopy will not be paid for these services.
The full list of codes is available here.
In addition CMS also released the list of the most recently approved CLIA waived tests for CY 2016. The list includes four new codes that must be billed with the –QW modifier. The list of newly approved waived tests includes CPT codes describing three specific assays and a revised code for presumptive drug class screening. Providers who possess a valid CLIA certificate of waiver, and submit claims for these codes will only be paid if they have appended the – QW modifier to the claim.
The full list of codes is available here.