ProMark® Risk Score

Covered: ProMark® is limitedly covered to help decide conservative (active surveillance) management for needle‑biopsy–proven localized prostate adenocarcinoma meeting the policy’s Very Low or Low risk definitions (specific T stage, Gleason ≤6, PSA ≤10, percent cancer in any core/PSA density cutoffs as applicable), with estimated life expectancy ≥10 years, no prior pelvic radiation or androgen‑deprivation therapy, no clinical metastasis or nodal involvement, and only when patients are candidates for and considering conservative therapy yet remain eligible for definitive treatment; tests outside these indications (intermediate/high risk, prior RT/ADT, life expectancy <10 years, clinical metastasis/nodes, or ordered by non‑CTR‑certified physicians) are excluded. Key requirements: the ordering physician must be enrolled/certified in the Metamark/MolDx ProMark CTR program, patients must be monitored per NCCN active surveillance guidelines, and mandatory registry enrollment and reporting (pre‑ and post‑test NCCN risk/treatment recommendations, ProMark score, final treatment decision, and immediate reporting of progression, metastasis, or prostate‑cancer deaths) plus documentation of T stage, Gleason, PSA, percent core involvement, PSA density, life expectancy, and no prior RT/ADT are required.