Noridian Healthcare Solutions LLC, a Medicare administrative contractor (MAC) based in Fargo, ND, has issued a favorable final local coverage determination (LCD) for the Prolaris prostate cancer test by Myriad Genetics Inc, Salt Lake City. The decision follows a similar final LCD from Palmetto GBA last January.

Photo Capone Mark crop 640

Mark Capone, Myriad Genetics.

“We are excited that Noridian has issued a final LCD for Prolaris, providing coverage for Medicare beneficiaries with localized prostate cancer,” says Mark Capone, president and chief executive of Myriad Genetics. “The decision is an important step in providing Medicare reimbursement for this life-saving test, and will significantly increase patient access to Prolaris testing in the United States.”

Prolaris is a 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance; high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy.

The final LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services website with an effective date of October 15, 2015, and provides Medicare coverage for prostate cancer patients defined as low- and very-low-risk by the National Comprehensive Cancer Network. The Medicare coverage decision extends reimbursement for testing to the approximately 60,000 patients diagnosed each year with localized prostate cancer in the United States who meet the criteria of a Gleason score ?6 and serum prostate specific antigen (PSA) level <10 ng/ml.

More than 220,000 new cases are diagnosed and 30,000 men will die from the disease each year, making prostate cancer the second leading cause of cancer death among men in the United States.1

For more information visit Myriad Genetics.

REFERENCE

  1. What are the key statistics about prostate cancer? [online] American Cancer Society. Available at www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics. Accessed on August 20, 2015.