Veridex, LLC announced that the Centers for Medicare and Medicaid Services (CMS) will determine payment rates for two new Current Procedural Technology (CPT) codes for circulating tumor cell (CTC) testing. CPT codes are assigned by the American Medical Association (AMA) to medical, surgical, and diagnostic services to communicate uniform information about medical services and procedures among physicians, patients, payers and others for administrative, financial, and analytical purposes.
Currently the Veridex CELLSEARCH® test, indicated for use in metastatic breast, colorectal, and prostate cancer patients, is the only CTC test that has been cleared through the FDA 510(k) review process. CTC testing was assigned Category III codes, which became effective January 1, 2012. These are temporary codes for emerging technology, services, and procedures.
In the past year, additional studies have been published in peer-reviewed medical journals highlighting the clinical utility of CTCs. On that basis, the AMA approved the Veridex request for two new Category I CPT codes for both the administration of the test and the professional interpretation of test results. This category of codes is reserved for services and procedures whose clinical efficacy has been well established and documented in U.S. peer-reviewed literature.
As part of the CMS payment process, an open meeting will be held to discuss the payment rate under the Clinical Lab Fee Schedule for the CTC test; Medicare will also establish a national reimbursement rate for the professional interpretation of test results. The payment rate determinations will be issued on or before November 1, 2012. Both new codes and payment rates will be effective and implemented January 1, 2013.
"We are thrilled that the AMA approved our request for Category I CPT codes," commented Vicki Vakiener, Global Oncology Business Leader, Veridex. "This reflects the growing evidence of the clinical utility of CTCs. These new CPT codes and established payment rates will enable access to CTC testing that can provide clinicians with increased information to support their clinical decisions."
About Circulating Tumor Cells
Circulating tumor cells are cancer cells that have detached from the tumor and are found at extremely low levels in the bloodstream. The value of capturing and counting CTCs is evolving as more research data is gathered about the utility of these markers in monitoring disease progression and potentially guiding personalized cancer therapy.
About CELLSEARCH® CTC Test
CELLSEARCH® is the first and only regulatory-cleared in vitro diagnostic (IVD) test to capture and count CTCs to determine the prognosis of patients with metastatic breast, colorectal or prostate cancer. The test can be administered at any time during the course of therapy as a routine blood test. It is used in combination with other tests and a clinician's assessment, to provide a more complete picture of a patient's prognosis.
About Veridex, LLC
Veridex, LLC, a Johnson & Johnson company, is an organization dedicated to providing physicians with high-value diagnostic oncology products. Veridex IVD products may significantly benefit patients by helping physicians make more informed decisions that enable better patient care. Veridex Clinical Research Solutions provide tools and services that may be used for the selection, identification and enumeration of targeted rare cells in peripheral blood for the identification of biomarkers, aiding scientists in their search for new, targeted therapies. For more information, visit www.veridex.com.