Billing and Coding: Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

Medicare covers targeted genomic sequence analysis panels for treatment of solid organ neoplasms when the panel contains at least five gene tests for molecular biomarkers that meet Medicare coverage criteria and when documentation shows the testing is expected to influence treatment. Pre-symptomatic screening and risk-assessment-only tests are not covered; inherited-condition genetic tests are limited to one lifetime test per beneficiary, while serial testing for acquired malignancies may be covered when medically reasonable and documented to affect management. Claims must include a valid ICD-10-CM diagnosis, appropriate ordering/provider identifiers, and detailed laboratory and test documentation (including LDT validity evidence and informed consent) to support billing.

"Coverage is allowed for targeted genomic sequence analysis panels for treatment of solid organ neoplasms when the panel is a DNA analysis panel containing at least 5 gene tests for molecular biomar..."