Agendia, a molecular cancer diagnostics company, announced today that Palmetto GBA, California's Part B Medicare administrator, has established coding guidelines for the company's MammaPrint test. MammaPrint is Agendia's FDA-cleared breast cancer recurrence test, which has been reimbursed by payors since 2008.
Patients across the United States can now submit claims for the MammaPrint test directly to Palmetto GBA in California where the test results are analyzed. The coding guidelines for healthcare providers are available at the Centers for Medicare and Medicaid Services (CMS) website at http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=30376lcd_version=5show=all.
Palmetto's decision to include MammaPrint in their reimbursement guidelines will provide greater access to this test for more women and their doctors when faced with difficult treatment decisions around breast cancer, said Dr. Richard Bender, Chief Medical Officer of Agendia.
MammaPrint is the first and only breast cancer recurrence test cleared by the U.S. Food and Drug Administration (FDA). FDA clearance under the in vitro diagnostic multivariate index assay (IVDMIA) guidelines requires clinical and analytical validation and reporting systems to ensure that patient safety and efficacy are addressed. Highly accurate, MammaPrint identifies patients with early metastasis-patients who are likely to develop metastases within five years following surgery. Several authoritative studies have shown that chemotherapy particularly reduces early metastasis risk. In planning treatment, the MammaPrint test results, in addition to other clinical information and pathology tests, provide doctors with a clear rationale to evaluate the benefits of chemotherapy
All MammaPrint tests are conducted in Agendia's CLIA-accredited service laboratory. Breast cancer recurrence assays currently marketed by other manufacturers have not been subject to the rigorous FDA clearance process.