Palmetto | GenomeWeb

Palmetto

It was a rough year for biotech stocks — the Nasdaq Biotech Index fell 22 percent even as the Dow gained 13 percent and the Nasdaq gained 8 percent.

The Medicare contractor is proposing to not cover Vectra DA, but to extend coverage for Prolaris, Xpresys, and DecisionDx-UM under specific circumstances.

Palmetto GBA revised a final LCD for comprehensive genomic profiling in lung cancer, and issued similar draft determinations in other cancers.

The panel's decisions could change the codes diagnostic companies use to bill payors for these tests, which could affect revenue.

In a final policy on comprehensive genomic profiling, Palmetto said that approved registries will have to commit to sharing data, among other requirements. 

The draft LCD comes one week after Noridian issued its own draft determination on the test.

Among the pre-analytical, analytical, and post-analytical requirements, Palmetto encouraged labs to submit variant data to the public database ClinVar.

The company's recent experience demonstrates the impasse between genetic test developers and payors about the types of clinical evidence needed for coverage.

The decision provides coverage for the test for US Medicare patients that meet the relevant eligibility criteria.

The decision follows a positive draft guidance from Palmetto GBA and several clinical care guidelines that acknowledge the validity of the test.

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