July 23, 2018—MDxHealth announced that Medicare administrative contractor Palmetto GBA has issued a positive final local coverage determination to expand Medicare coverage of the ConfirmMDx for Prostate Cancer test.
The final LCD, which expands Medicare coverage to all providers, will be effective Sept. 3. The prior LCD, in 2014, limited coverage to only those providers enrolled in a certification and training registry program. The new LCD removes other conditions to continuing Medicare coverage by deleting references to the Pascual clinical study, removing patient number limitations, and eliminating certain other conditions associated with the former MolDX coverage with data development program.
“The expanded Medicare coverage of ConfirmMDx demonstrates the clinical value of our test to reduce unnecessary invasive clinical procedures,” Jan Groen, PhD, CEO of MDxHealth, said in a statement. “With this streamlined LCD, we can now broaden the impact of ConfirmMDx, facilitating access for all men covered by Medicare.”