Palmetto Releases Draft LCD for Prostate Cancer Risk Stratification Tests

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.

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.

Source: https://www.genomeweb.com/reimbursement-news/palmetto-releases-draft-lcd-prostate-cancer-risk-stratification-tests