NEW YORK (GenomeWeb) – The Centers for Medicare & Medicaid Services finalized a coverage policy to begin reimbursing MDxHealth's ConfirmMDx prostate cancer test effective Nov. 3.
Medicare contractor Palmetto GBA issued a draft local coverage decision (LCD) a few months ago proposing to cover the test only when it is performed by doctors enrolled in a MolDx-approved certification and training registry program, or CTR.
The ConfirmMDx test gauges the methylation status of biomarkers (GSTP1, RASSF1, and APC) associated in the published literature with prostate cancer. MDxHealth sells the test as a tool that doctors can use to gain further prognostic insights into patients with high risk factors for prostate cancer and reduce the need for repeat biopsies.
The final LCD decision reiterates the requirement that reimbursement is contingent on physicians' enrollment in the registry program. Additionally, Palmetto could potentially cover the test for additional Medicare beneficiaries based on an interim analysis of a prospective, randomized clinical utility trial for ConfirmMDx, called PASCUAL.
If the test lowers the repeat biopsy rate in the trial at interim analysis, then Palmetto will allow the physicians participating in the trial to enroll in the registry, "effectively increasing the number of Medicare patients covered" for testing, Palmetto said. But if the interim analysis demonstrates poor accrual or shows that the test doesn't "substantially" reduce repeat biopsies then Palmetto will limit coverage for 1,200 patients to be tested or cover ConfirmMDx tests for a duration of three years, whichever comes first.
MDxHealth has projected that it can test 1,200 patients within PASCUAL and in the registry by the second quarter of 2016. Palmetto will lift the coverage restrictions and the registry requirements for ConfirmMDx if the PASCUAL findings are positive.
MDxHealth CEO Jan Groen said in a statement that Palmetto's decision is an "important milestone" for the firm. "Medicare's decision will facilitate negotiations with private insurance companies," he added.