Stacey Posted Fri 04th of January, 2019 16:40:55 PM
We have developed a LDT using flow cytometry for the analysis of solid lung cancer tumors. We have identified specific methodology CPT codes associated with flow markers used with this test. The methodology CPT codes accurately describe the test. It is our understanding that the FDA is not involved with assigning and/or regulating CPT codes for LDTs. Is that correct? Can you provide some further explanation of CPT methodology codes and their use in clinical assays?
SuperCoder Answered Mon 07th of January, 2019 08:06:28 AM
Thanks for your question.
CMS finalized a National Coverage Determination (NCD) that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory, or stages III or IV cancer).
This NCD recognizes the importance of analytical and clinical validation of the diagnostic laboratory test that is part of FDA approval or clearance and provides national coverage after demonstration that use of the diagnostic laboratory test guides the management and treatment of the patient improves health outcomes. Tests that gain FDA approval or clearance as an in vitro companion diagnostic will automatically receive full coverage under this final NCD, provided other coverage criteria are also met.
Coverage determinations for other diagnostic laboratory tests using NGS for Medicare patients with advanced cancer will be made by local Medicare Administrative Contractors. In addition, after considering all public comments, this final decision expanded coverage to patients with relapsed, refractory or stage III cancers. The final decision also extends coverage to repeat testing when the patient has a new primary diagnosis of cancer.
You may report the normal CPT codes (e.g. 86356) for flow cytometry and provide a separate letter to the insurance stating the need for LDTs.
You may find more information on the following link: https://www.cms.gov/newsroom/press-releases/cms-finalizes-coverage-next-generation-sequencing-tests-ensuring-enhanced-access-cancer-patients
Please feel free to write if you have any question.