Palmetto GBA, the designated national contractor for Oncotype DX Colon Cancer Assay, has determined that the test
Meets criteria for analytical and clinical validity and clinical utility as a reasonable and necessary Medicare benefit. Effective September 18, 2011, Palmetto GBA will reimburse Oncotype DX® Colon Cancer Assay services for patients diagnosed with Stage II colon cancer.
The Oncotype DX Colon Cancer Assay indicates how likely it is that stage II colon cancer will return (recur). It tests tumor tissue for twelve genes to develop a recurrence score that patients and their doctors can use in combination with other clinical information to make decisions about having chemotherapy after surgery.
The test does not predict whether or not chemotherapy will reduce risk of recurrence, but it does indicate risk for recurrence.
The Oncotype DX test is done with tumor tissue removed during colon cancer surgery and preserved in paraffin blocks. Your doctor can help you obtain that tissue from the pathology laboratory where it was analyzed after your operation and stored.
Genomic Health, which developed and markets the Oncotype DX Colon Cancer Assay, warns that while Palmetto GBA processes original Medicare claims nationwide, Medicare Advantage plans may not all cover the test. If you have Medicare Advantage, check with your plan for coverage information.
For other insurance programs Genomic Health’s Genomic Access Program (GAP) will help determine coverage, obtain prior authorization if necessary, and help with appeals if the claim is denied.
Genomic Health also has a financial assistance program to help uninsured or underinsured patients with the cost of the test.
For help with coverage questions call Genomic Health Customer Service at 866-ONCOTYPE (866-662-6897).
More information about how the 12-gene genomic test was developed and validated from Fight Colorectal Cancer.