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Medicare Contractor Quickly Retires Draft LCD on Breast Cancer Biomarker Tests Citing New Data

NEW YORK (GenomeWeb) – Due to the availability of new data, Medicare contractor Noridian said it will retire a recently issued draft local coverage determination in which it proposed to limit coverage for a number of biomarker tests to guide decisions about adjuvant chemotherapy in breast cancer patients (see pdf below).

According to the draft LCD issued last week, Noridian wanted to cover Genomic Health's Oncotype DX, NanoString's Prosigna, Sividon Diagnostics' EndoPredict, BioTheranostics' Breast Cancer Index, as well as tumor-associated proteolytic factors uPA & type 1 inhibitor PAI-1 for breast cancer patients who are estrogen or progesterone receptor positive, HER2 negative, and whose disease hasn't spread to the lymph nodes. However, Noridian had said it would not cover these same tests for ER/PR positive, HER2 positive, node-positive, or triple-negative breast cancer.

Further, Noridian had said that it would not cover Agendia's MammaPrint, NeoGenomics' Mammostrat, IHC-4, tumor infiltrating lymphocytes, circulating tumor cells, and Ki67 for "any reason."

As previously reported by GenomeWeb, the draft LCD was based on guidelines from the American Society of Clinical Oncology's Biomarker Expert Panel, but did not reflect the latest published data from the large studies, such as TAILORx and MINDACT. Genomic Health had said it would discuss recent data on Oncotype DX with the Medicare contractor.  

"Since the drafting of this policy, additional information has been identified that we feel will significantly impact this policy and will likely result in a significant revision," Noridian said this week. "As such, we are retiring this draft LCD."

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