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Palmetto Releases Draft LCD for Prostate Cancer Risk Stratification Tests

NEW YORK – Medicare Administrative Contractor Palmetto GBA released a draft local coverage determination on Thursday proposing limited coverage of prostate biomarker diagnostic tests.

The proposed LCD would provide coverage for tests that help risk stratify patients who may benefit from a prostate biopsy when the patient is a candidate for prostate biopsy or repeat prostate biopsy and either has not had a prostate biopsy or has had a previous nonmalignant or negative but abnormal histopathology finding. Patients who are under consideration for a repeat biopsy must have undergone repeat prostate specific antigen, or PSA, testing and/or digital rectal exam, or DRE, testing and the prior biopsy must have occurred less than two years ago.

For patients older than 75, PSA or repeat PSA must be between 3ng/mL and 10ng/mL or DRE findings must be "very suspicious for cancer," according to the coverage determination. For those younger than 75, PSA must be between 4ng/mL and 10ng/mL or DRE results must be suspicious for cancer.

Other coverage terms are that the patient would benefit from treatment of prostate cancer, the patient is within the population the test was validated for, the analytes measured by the test have demonstrated clinical validity and utility, and the physician ordering the test is a specialist in the management of prostate cancer. In addition, if the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm.

Although Palmetto did not say which specific tests would be covered under the decision, MDxHealth said in a statement that the evidence required to show clinical utility mentioned in the LCD would support coverage for its SelectMDx test for prostate cancer. The company's mRNA-based RT-PCR test measures expression of the HOXC6, DLX1, and KLK3 genes and is performed on a urine sample.

The comment period for the proposed coverage determination began on Thursday and will end on July 3.