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Local Coverage Determinations Roundup: Transplant Genomics, Opko Health

NEW YORK (GenomeWeb) – Medicare Administrative Contractors released draft local coverage determinations (LCDs) for a number of molecular diagnostics this week.

Below is a list and brief description for each of the LCDs. Each listing starts with the Medicare contractor that made the decision.

Final LCDs:

Noridian: Transplant Genomics' TruGraf Blood Gene Expression Test**

Noridian issued a final LCD that aligns with Palmetto's earlier coverage determination for this test. The contractors will provide limited coverage for the test as an alternative to surveillance biopsies in kidney transplant patients more than 90 days after they've received the organ. Wisconsin Physicians Service Insurance Corporation has also agreed to cover the test for this indication. 

First Coast Service Options: Opko Health's 4Kscore

The contractor issued a final LCD in line with coverage terms previously issued by Novitas. Like Novitas, First Coast will cover the test for patients 45 years or older with a confirmed moderately elevated level of prostate-specific antigen (PSA), between 3 ng/mL and 10 ng/mL, and no other indication or contraindication for prostate biopsies. If the patient has major risk factors for prostate cancer or less than a 10-year life expectancy, the test will not be covered. The test will also not be covered if there's a persistent and significant increase in the patient's PSA, or if a digital rectal examination (DRE) is performed and there's a suspicion of cancer. CMS noted that there must be evidence of shared decision-making between the physician and the patient to receive coverage.

**Palmetto administers the MolDX program, in which three other Medicare Administrative Contractors (MACs) participate, including Noridian, CGS, and Wisconsin Physicians Service Insurance Corporation. Each MAC issues its own draft and final policy to align with Palmetto’s coverage terms for a specific test.