Billing Beat

CPT Editorial Panel Authorizes the Establishment of a New Clinical Laboratory Test Section

November 30, 2015

The Protecting Access to Medicare Act of 2014 (PAMA)  mandates the creation of specific HCPCS codes for Advanced Diagnostic Laboratory Tests (ADLTs) and Clinical Diagnostic Laboratory Tests (CDLTs) that are cleared or approved by the FDA.  On September 25, 2015, CMS proposed the creation of G codes to identify new and existing ADLTs and new and existing CDLTs (that are not ADLTs) that are cleared or approved by the FDA if a specific HCPCS code does not already exist.  Further, the Agency proposes to expressly prohibit the use of unlisted and Not Otherwise Classified (NOC) codes.  As noted by the CMS, G codes are temporary HCPCS Level II codes used by CMS to identify professional health care procedures and services, including laboratory tests that would otherwise be identified by a CPT code, but for which there is no CPT code. The new section established by the Panel provides an infrastructure whereby a clinical laboratory or manufacturer that meets certain criteria may request a code to more specifically identify their test.  This section is separate from the Category I Pathology and Laboratory section and will include ADLTs and CDLTs as defined under PAMA.  The clinical laboratory or manufacturer that offers the test must request the code.  It is envisioned that the codes in this new section will be issued on a quarterly basis and effective the following quarter to allow payers time to load them into their systems.  The Panel would be responsible for verification of the information submitted and codification of tests in this section.  The Panel will not determine whether or not the test meets the criteria of an ADLT, which will be determined by CMS. 

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