Molecular subtyping test for bladder cancer gains Medicare coverage

June 7, 2021

Veracyte announced that Medicare Administrative Contractors Palmetto GBA, WPS, and CGS Administrators have finalized their coverage policies for Decipher Bladder, a genomic subtyping tool that helps physicians manage treatment decisions for patients with bladder cancer, according to a news release from the company.

Veracyte said that these local coverage determinations (LCDs) make Decipher Bladder the first genomic test to be covered by Medicare for such patients. Developed through the Medicare MolDX program, the policies will become effective July 18, 2021, and provide a framework for other participating MACs to follow.

The company also said Noridian Healthcare Solutions, another Medicare Administrative Contractor, is expected to similarly finalize its draft LCD, which will make Decipher Bladder a covered benefit for more than 62 million Medicare beneficiaries.

In the United States, more than 80,000 individuals are diagnosed with bladder cancer annually, approximately 44,000 of which will have the non-metastatic, Stage I-IIIa disease indicated in these policies.

Decipher Bladder is a genomic test that measures the molecular profile of bladder cancer using gene expression analysis from transurethral resected bladder tumor specimens. It was developed for bladder cancer patients with muscle-invasive disease who face the question of immediate cystectomy or systemic treatment in the neoadjuvant setting prior to cystectomy (NAC). The assay results are reported as one of five molecular subtypes (Luminal, Luminal-Infiltrated, Basal, Basal Claudin Low or Neuroendocrine-like), each of which has distinct biological composition, clinical behavior and predicted benefit from NAC.

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