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Local Coverage Determinations Roundup: Transplant Genomics, DermTech, GenomeDx, and More

NEW YORK (GenomeWeb) – Medicare Administrative Contractors recently released a number of local coverage determinations (LCDs), including draft policies for Transplant Genomics' TruGraf Blood Gene Expression Test, DermTech's Pigmented Lesion Assay, and Decipher Biosciences’ Decipher Prostate Cancer Classifier.

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


Draft LCDs:

Palmetto: Transplant Genomics' TruGraf Blood Gene Expression Test

The contractor has proposed to cover this test as an alternative to biopsies in kidney transplant patients more than 90 days after they received their transplants. The DNA microarray test assesses differentially expressed genes in blood.

Palmetto: DermTech's Pigmented Lesion Assay

The contractor has proposed to cover this non-invasive RNA gene expression test to rule out primary cutaneous melanoma and to help decide if patients with skin lesions that display one or more clinical characteristics suggestive of cancer should be biopsied. The test, which obtains skin samples non-invasively through an adhesive skin patch, must be ordered by a doctor or a healthcare professional with expertise in melanoma.

Palmetto: Decipher Biosciences' Decipher Prostate Cancer Classifier

The contractor has issued two draft LCDs for the Decipher prostate cancer classifier for men with unfavorable intermediate risk of disease and favorable intermediate risk of disease. Palmetto, Wisconsin Physicians Service Insurance Corporation, and CGS Adminsitrators earlier this year also finalized local coverage for the test for men who are deemed low risk and very low risk for prostate cancer by National Comprehensive Cancer Network’s guidelines, when certain criteria are met. 

Final LCDs:

Wisconsin Physicians Service Insurance Corporation: Veracyte's Envisia Genomic Classifier**

The contractor has issued a coverage decision in line with Palmetto's earlier final LCD to cover Veracyte's Envisia Genomic Classifier assay to clarify the diagnosis of patients with interstitial lung disease who are suspected of having idiopathic pulmonary fibrosis.

CGS Administrators: Inivata's InVisionFirst-Lung**

The contractor has issued a coverage decision to align with Palmetto's final LCD on Inivata's InVisionFirst-Lung, a circulating tumor DNA NGS test that assesses alterations in 36 genes. The test is intended to help doctors treat advanced non-small cell lung cancer patients.  


**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.