NEW YORK (GenomeWeb) – MDxHealth announced today that Medicare administrative contractor Palmetto GBA has issued a positive final Local Coverage Determination to expand Medicare coverage for the firm's ConfirmMDx for Prostate Cancer test.
The final LCD, which expands Medicare coverage of the test to all Medicare providers, becomes effective on Sept. 3. Â The prior LCD, first established in 2014, limited coverage to only those providers enrolled in a certification and training registry program. Further, 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, MDxHealth said.
"Palmetto GBA will provide limited coverage for the ConfirmMDx epigenetic assay for prostate cancer to reduce unnecessary repeat prostate biopsies. Palmetto recognizes that evidence for clinical utility for ConfirmMDx in males with previous negative prostate biopsy who are being considered for repeat biopsy is promising with evidence of some clinical utility at the current time," Palmetto said in its final LCD. "Palmetto believes the clinical studies planned will generate sufficient additional data to demonstrate the utility of ConfirmMDx in males with previous negative prostate biopsy who are being considered for repeat biopsy."
Palmetto also noted that continued coverage of the test for men with previous negative prostate biopsies and who are being considered for repeat biopsy will dependent on a semi-annual review of interim data, peer-reviewed publications, and/or presentations of clinical utility data demonstrating that ConfirmMDx directs patient management for men with previous negative prostate biopsies as measured using clinical endpoints in one or more studies.
ConfirmMDx uses methylation-specific PCR to assess the methylation status of three biomarkers — GSTP1, RASSF1, and APC — associated with prostate cancer, and is intended for use in patients with high-risk factors such as elevated or rising PSA levels, and who are being considered for repeat biopsy.
"The expanded Medicare coverage of ConfirmMDx demonstrates the clinical value of our test to reduce unnecessary invasive clinical procedures," MDxHealth CEO Jan Groen said in a statement. "With this streamlined LCD, we can now broaden the impact of ConfirmMDx, facilitating access for all men covered by Medicare."