Palmetto GBA, Columbia, SC, a Medicare administrative contractor (MAC) that assesses molecular diagnostic technologies through its MolDx program, has issued a favorable final local coverage determination (LCD) for the Prosigna breast cancer assay by NanoString Technologies Inc, Seattle, a provider of life science tools for translational research and molecular diagnostic products.
“We are delighted by the favorable LCD published by Palmetto’s MolDx team. The policy decision is expected to increase patient access across Prosigna’s entire intended-use population, including patients with both node-negative and node-positive breast cancer,” says Brad Gray, president and CEO of NanoString. “The MolDx process is viewed as one of the most sophisticated and influential technology assessments in the United States, and the positive MolDx policy demonstrates the effectiveness and impact of our reimbursement team.”
The final LCD, which confirms the coverage policy for Medicare beneficiaries, includes reimbursement coverage for postmenopausal patients with ER+, lymph node-negative, stage I or II breast cancer; and ER+, lymph node-positive (1–3 positive nodes), stage II breast cancer.
The Prosigna assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded breast tumor tissue previously diagnosed as invasive breast carcinoma.
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer.
The LCD is consistent with the draft guidance issued by Palmetto GBA on May 14. Following a public comment period that ended on July 24, Palmetto GBA finalized and published the guidance, which becomes effective for services on or after October 1, 2015. The final LCD applies to the J11 jurisdiction, comprising North Carolina, South Carolina, Virginia, and West Virginia. Other Medicare jurisdictions participating in the MolDx program may choose to adopt the same coverage policy in the future.
The draft LCD (DL36125) is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services website, accessible via www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx.
For further information, visit NanoString.