NEW YORK – Medicare administrative contractor National Government Services has released an updated local coverage determination expanding coverage of Bio-Techne's ExoDx Prostate Test.
Under the updated LCD, which goes into effect March 1, the contractor will cover the EPI test once per year in patients with at least one prior negative biopsy who need a repeat biopsy and are thought to be at higher risk. Patients must have moderately elevated prostate specific antigen levels, no other relative indication for prostate biopsy, and no other relative contraindication for prostate biopsy. Relative indications include a positive multiparametric MRI, a positive prior biopsy, a digital rectal exam suspicious for cancer, or other major risk factor for prostate cancer, such as a first-degree relative with prostate cancer. Relative contraindications include a life expectancy of less than 10 years, invasive treatment for benign prostatic disease, or active prostatitis on antibiotics.
The ExoDx test joins a slate of other tests covered by the LCD for that indication, including Opko Health's 4K Score, MDxHealth's Confirm MDx, and LynxDx's MyProstate Score.
Coverage was expanded in light of an update from the National Comprehensive Cancer Network released in January that includes the ExoDx test on the list of assays that should be considered for patients with a prior negative biopsy thought to be at higher risk for aggressive prostate cancer.
"This important coverage determination ensures that more patients will have access to noninvasive testing before moving forward with painful, risky, and potentially unnecessary biopsy procedures," Kim Kelderman, president of Bio-Techne's diagnostics and genomics segment, said in a statement.