CMS expands coverage for breast cancer test

May 12, 2021

Hologic announced that its subsidiary, Biotheranostics, has received broader Medicare coverage for its Breast Cancer Index test under an expanded Medicare Local Coverage Determination from the Centers for Medicare & Medicaid Services, according to a news release from Hologic.

Under the new criteria, Breast Cancer Index is now covered for post-menopausal women diagnosed with early-stage node-positive (one to three axillary lymph nodes), non-relapsed, estrogen receptor (ER) and/or progesterone receptor (PR) positive, HER2 negative breast cancer. Previously, Medicare covered the test only for patients with node-negative, non-relapsed, ER and/or PR positive, HER2 negative breast cancer. Therefore, the expanded coverage increases the availability of Breast Cancer Index testing with no cost to Medicare beneficiaries who meet the LCD criteria.

For hormone receptor positive (HR+) post-menopausal breast cancer patients on extended endocrine therapy, the side effects and toxicities of treatment often have significant negative effects on health and quality of life, such as osteoporosis, bone fractures and joint pain. As a result, knowing when extended endocrine therapy will benefit a patient is as important as avoiding it when it will not make a difference, Hologic said. The Breast Cancer Index test can help personalize extended endocrine treatment for all HR+ early-stage patients.

The ratio of breast cancers diagnosed as node-negative or node-positive varies year to year, but according to data published by the National Cancer Institute1 in 2021, approximately 85% of early-stage, HR+ breast cancers were node-negative and 15% were node-positive that year, Hologic said. This means that approximately 25,000 more women every year will be eligible for testing with Breast Cancer Index based on the expanded coverage.

Breast Cancer Index is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. Hologic says it is the only validated, commercially available test that predicts benefit from extended endocrine therapy.

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