NEW YORK (GenomeWeb) – Genomic Health announced today that national Medicare contractor Palmetto GBA has issued a favorable final local coverage determination approving coverage of the company's Oncotype DX prostate cancer test for qualified patients.
The decision by Palmetto finalizes the draft LCD issued by the contractor earlier this year, under which coverage for Oncotype DX prostate is subject to several criteria, including that testing may only be performed by physicians enrolled in a Palmetto MolDX-approved Certification and Training Registry program, and that physicians must monitor tested patients for disease progression and report any cases of metastasis or prostate cancer deaths in patients who were deemed low risk by the assay.
Oncotype DX prostate provides a genomic assessment of a tumor's aggressiveness in order to help doctors decide which patients are at low enough risk that they can be more conservatively managed, avoiding costly medical interventions.
"With Medicare's coverage, each year, nearly 60,000 prostate cancer patients and their physicians will now have the opportunity to make more optimal treatment decisions based on the unique biological information revealed by the Oncotype DX Genomic Prostate Score," Genomic Health President and CEO Kim Popovits said in a statemet.
The effective date for coverage under the newly final LCD will begin after a 45-day notice period, the company said.