On June 17, 2016, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule. This Final Rule implements the Protecting Access to Medicare Act provisions pertaining to pricing and coding for clinical laboratory tests covered on the Medicare Clinical Lab Fee Schedule, as well as reporting requirements for clinical laboratories performing these tests.
The Final Rule requires that CMS:
- Issue Healthcare Common Procedure Coding System (HCPCS) codes to identify new advanced diagnostic laboratory tests (ADLTs), and clinical tests that are cleared or approved by the Food and Drug Administration (referred to as Clinical Diagnostic Laboratory Tests, or CDLTs) if an applicable CPT code (HCPCS level I) does not exist and
- Provide, upon request, either a HCPCS code or unique identifier for test tracking and monitoring.
In order to address these coding provisions, the CPT Editorial Panel approved in November 2015, and finalized at the February 2016 panel meeting, the new Proprietary Lab Analyses (PLA) section of the CPT code set. In addition, the panel approved the creation of the Proprietary Laboratory Analyses Technical Advisory Group.
The AMA CPT Proprietary Laboratory Analyses Technical Advisory Group (PLA-TAG)
An important part of the development of this new set of codes is that industry and other stakeholders, including subject matter experts, actively participate in the PLA process. To that end, the Panel created the PLA-TAG to advise the Panel on applications received for codes to be added to the new PLA section of CPT.
Along with representation by the Panel and certain Panel workgroups, the PLA-TAG is composed of individuals with expertise relating to the services covered under the CPT PLA section. These include, but are not limited to, members from various industry segments such as independent labs performing molecular diagnostic services, private payers, professional/industry organizations, commercial labs, academia and private practitioners.
Members of the PLA-TAG will play a crucial role in the PLA code creation process by reviewing CPT PLA code change applications and making recommendations regarding these requests for CPT codes that describe ADLTs or CDLTs.
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