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Palmetto Finalizes Positive LCD for Prostate Cancer Risk Tests

NEW YORK – Medicare Administrative Contractor Palmetto GBA has finalized a local coverage determination under its MolDX program that would provide coverage, within specific parameters, for the use of molecular biomarkers to add to the risk stratification of patients being screened for prostate cancer.

As a foundational LCD, the coverage is not test brand-specific, but rather outlines coverage for any test that meets its criteria and passes a technology assessment by MolDX. It becomes effective July 3, 2022.

The LCD defines two applications of molecular biomarkers to risk-stratify patients at increased risk for prostate cancer: a non- or minimally invasive test whose results can inform the decision to perform an initial biopsy, or a test that can further refine risk when a biopsy has been performed but the presence or absence of cancer still isn't clear to pathologists.

In the first setting, Palmetto will pay for genomic tests as long as patients don't already have a prostate cancer diagnosis and they are a candidate for a biopsy based on professional guidelines.

For testing to be covered, patients must have specific PSA levels, depending on age, or have suspicious findings on a digital rectal exam. They also must not have had a previous biopsy, or if they have, the findings must have been negative or "non-malignant but abnormal."

The CMS contractor also stated that multiple tests won't be reimbursed for a given clinical indication (pre- or post-biopsy), unless a second test is reasonable and necessary as an adjunct to the first test, according to criteria established in the policy.

The LCD cites National Comprehensive Cancer Network guidelines that endorse the use of Bio-Techne's ExoDx Prostate, and MDxHealth's SelectMDx and ConfirmMDx, among other tests, mainly PSA-based assays. But Palmetto notes that reference to these specific tests doesn’t imply coverage. All tests, as stated, must pass MolDX's technical assessment.

Among technical requirements, tests that use an algorithm must have been validated in an independent cohort from their development cohort. Assays also must have demonstrated both clinical validity and clinical utility in the peer-reviewed published literature.

Summarizing evidence, including studies of specific tests like MDxHealth's SelectMDx, Palmetto stated that its review suggests there is "adequate evidence" to show that information provided by validated molecular biomarker tests for prostate cancer changes physician management in a way that improves outcomes.

"Tests that fulfill all criteria outlined in this policy will similarly be considered for coverage," the LCD states.

Although it did not state that it has undergone a tech assessment by MolDX, MDxHealth said in a press release that it believes that when the LCD becomes effective, it will support coverage of SelectMDx.

"We are certain that our clinical data for the SelectMDx test, adoption from our urology customer base, and inclusion in the NCCN Guidelines merits coverage by Medicare," MDxHealth CEO Michael McGarrity said in a statement.

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