Palmetto Draft LCD Proposes Limited Coverage for Guardant360

NEW YORK (GenomeWeb) – Medicare contractor Palmetto GBA has released a draft local coverage determination for Guardant Health’s comprehensive liquid biopsy test Guardant360, proposing limited coverage for the test in patients with advanced non-small cell lung cancer.

According to the LCD, released under Palmetto’s MolDx program, coverage for the test would be restricted to patients with cancers at stage IIIB or higher, and performed either at diagnosis or at progression.

For Guardant360 to be covered at diagnosis, patients must not have been genomically tested for EGFR alterations, ALK and ROS1 rearrangements, or PD-L1 expression, and they must not be eligible for tissue-based testing — either because their biopsy tissue is insufficient, or because a biopsy is not possible for medical reasons.

At progression, the LCD proposes coverage for patients who, again, have never been tested for the targets in question and for whom tissue-based testing is infeasible. It also provides coverage for patients who are progressing on an EGFR tyrosine kinase inhibitor regardless of their history of genetic testing.

Repeat testing in the context of therapeutic monitoring is not a Medicare benefit, according to the draft. Neither is use of Guardant360 for assessing germline variants.

Supporting the draft, Palmetto cited

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