Genomic Tests for Prostate Cancer Risk Stratification Are Now Covered

A newly finalized local coverage determination (LCD) from Medicare Administrative Contractor (MAC) Palmetto GBA is good news for labs that manufacture or use molecular biomarkers for risk stratification of patients being screened for prostate cancer. Here’s a quick briefing on the new coverage rules.

Coverage Requirements

Molecular biomarkers can be used to stratify risk of patients who are at higher risk of prostate cancer. Based on its review, Palmetto concluded that there’s “adequate evidence” to show that the information provided by validated molecular biomarker tests for prostate cancer changes physician management in a way that improves outcomes. Specifically, the new LCD, which officially takes effect on July 3, 2022, establishes coverage criteria for two applications:

Pre-Biopsy Test: The LCD provides for coverage of non- or minimally invasive tests to guide the decision of whether to perform an initial biopsy, as long as the patient:

• Hasn’t previously been diagnosed with prostate cancer;
• Is a candidate for a biopsy based on professional guidelines;
• Is at elevated risks of prostate cancer due to either having specifically designated PSA levels based on age or suspicious findings from a digital rectal exam; and
• Has either not had a previous biopsy or, if he has, the findings were negative or “non-malignant but abnormal.”

Post-Biopsy Test: Palmetto will also cover genomic prostate cancer tests that are provided to further refine patient’s risks after a biopsy in which the results were inconclusive and didn’t enable pathologists to make a definitive determination about whether cancer is or isn’t present.

Limitation: Multiple tests for a given clinical indication, whether pre- or post-biopsy, won’t be reimbursed unless a second test is reasonable and necessary as an adjunct to the first test, according to the LCD.

Covered Test Products

The LCD isn’t brand-specific. Any test can qualify for coverage as long as it meets the coverage criteria and passes a technology assessment performed under Palmetto’s MolDX program. Technical requirements apply. Among other things, tests using an algorithm must be validated in a cohort that’s independent from their development cohort. Assays must also demonstrate both clinical validity and clinical utility in peer-reviewed published literature. While the LCD cites Bio-Techne's ExoDx Prostate, MDxHealth's SelectMDx and ConfirmMDx, and a number of prostate specific antigen (PSA)-based assays whose use National Comprehensive Cancer Network (NCCN) guidelines endorse, Palmetto stresses that being referenced by NCCN doesn’t imply coverage.