Myriad's Prostate Cancer Test Receives Draft Medicare Coverage

Myriad Genetics, Inc., announced today that the Medicare Administrative Contractor (MAC) that has jurisdiction over most molecular diagnostic tests has issued its draft notice on how Medicare will provide reimbursement for Prolaris, a test that Myriad has developed to guide treatment decisions in prostate cancer.

The draft local coverage determination (LCD) has been posted online by the MAC Palmetto GBA, according to a statement released by Myriad. The language calls for reimbursement for approximately 50% of prostate cancer patients defined as low and very low risk. Per Medicare rules, the draft LCD is subject to a minimum 45-day public comment period; once comments are considered, the final language goes into effect after a minimum notification period of 45 days.

Palmetto GBA’s action on reimbursement for a molecular diagnostic test in prostate cancer is sure to draw attention in the industry, given the disputes with the Centers for Medicare and Medicaid Services (CMS) on which tests deserve reimbursement. In recent years, CMS generally, and Palmetto GBA, specifically, have been under scrutiny over the MolDx program, which was developed to handle reimbursement questions involving this emerging industry. MolDx increasingly required testing companies to build evidence that demonstrated “clinical utility,” a standard that means a test makes a difference in physicians’ treatment decisions.

But what should be required became a matter of disagreement. On April 18, 2014, the California Clinical Laboratory Association sued the US Department of Health and Human Services, of which CMS is a part, over what the plaintiffs claimed was an unlawful transfer of CMS’ authority to set reimbursement policy and, especially, to allow diagnostic companies to appeal an unfavorable LCD.

Separately last spring, Myriad Genetics submitted a filing to Palmetto GBA that its spokesman described as “the most comprehensive dossier for a molecular diagnostic test ever,” and initially hoped for a decision on reimbursement as early as June 2014. In May, Myriad presented results on Prolaris at the meeting of the American Urological Association in Orlando, Florida. These results were covered in the August issue of Evidence-Based Oncology, a news publication of The American Journal of Managed Care.

Prolaris, which came on the market in 2010 and costs $3400,^, is a 46-gene test designed to gauge the aggressiveness of prostate cancer in individual patients, based on the expression of cell cycle regulator genes. Unlike the prostate-specific antigen (PSA), which offers a snapshot of the cancer on a given day, Prolaris’ supporters say it offers a window into the future, assigning a score that increases along with the risk of progression.

"We are very excited by this draft coverage determination as a first step in ensuring that all Medicare prostate cancer patients will have access to Prolaris testing which we believe provides the highest quality and most accurate assessment of their cancer’s aggressiveness," Pete Meldrum, president and CEO of Myriad, said in a statement. "Prolaris is the only test that can use the initial biopsy to accurately predict cancer-specific death in men with prostate cancer. In multiple clinical validation studies, Prolaris has been shown to be a much stronger indicator of clinical outcomes than adverse pathology for patients across all risk categories."

Around the Web

Studies See Value of Prostate Cancer Diagnostic Tests, but will CMS Pay for It?