Medicare is starting to cover genetic prostate cancer tests and is considering the possibility to expand the coverage to a national level. The U.S. national health care program is going to provide diagnostic examination to assess the risk of developing prostate cancer in men, and is also planning on consulting healthcare stakeholders, in order to evaluate the viability of offering it nationwide, as announced by a Medicare administrative contractor.
Even though the disease is the second most common type of cancer diagnosed in American men, causing the death of approximately 28,000 people, according to the Centers for Disease Control and Prevention, Medicare does not cover genetic prostate cancer tests, which are key in assessing a patient’s probability of suffering from the disease. Even now, when it has decided to partially cover Prolaris, an exam developed by the publicly traded biotechnology company Myriad Genetics, there are several conditions.
In order to receive the Prolaris test, patients must meet a series of criteria, including being considered low risk or very low risk, having a life expectancy of at least ten years and having the test ordered by a certified clinician from Myriad’s database, according to the local coverage determination proposed by the Centers for Medicare & Medicaid Services (CMS), which can be fully consulted here.
The coverage will be submitted to a public comment period, which will last between November 10 and December 25. During this time, Myriad will provide information to Medicare that they believe will help support the national coverage of the test to all patients, and not only the low risk ones, as stated by a spokesman of the company. If Medicare approves the national coverage of the genetic prostate cancer test, it could effectively start next year. Myriad’s spokesman also mentioned that potential financial ramifications could be discussed within few weeks, during its first-quarter call with investors.
Although Prolaris is a genetic prostate cancer test, it is different from other early-stage screening, since standard examinations measure the blood levels of the prostate-specific antigen (PSA) protein, in order to determine the presence of the tumor and its associated severity. Prolaris, which was released in 2010 and has a cost of $3,400, examines 46 genes of the patient’s DNA to evaluate their risk for prostate cancer.
The decision to cover Prolaris test in particular, may be related to the fact that exams based on PSA measurements are currently receiving several critics from both physicians and the U.S. Preventive Services Task Force, since it can lead to false positives. If so, patients would be submitted to unnecessary treatment, which could result in further health complications. On contrary, genetic tests have received several positive recommendations.