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Local Coverage Determinations Roundup: Guardant Health, Natera, Transplant Genomics, and More

NEW YORK (GenomeWeb) – Medicare Administrative Contractors recently released a number of local coverage determinations (LCDs) to align their coverage terms with Palmetto’s MolDx program.

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:

Wisconsin Physicians Service Insurance Corporation: Guardant Health’s Guardant360 Plasma-Based Comprehensive Genomic Profiling Test**

The contractor has issued draft coverage terms that align to Palmetto’s draft LCD, which propose to extend coverage for the 73-gene Guardant360 liquid biopsy test in more than a dozen solid tumor types where biomarker information is needed to inform their treatment.

Wisconsin Physicians Service Insurance Corporation: Natera’s Prospera Kidney Transplant Test**

The contractor aligned its draft coverage terms with Palmetto’s earlier proposed coverage decision for Prospera. The donor-derived cell-free DNA test is intended to be used with standard assessments to rule in or rule out kidney rejection in transplant patients and decide if a diagnostic biopsy is needed. CGS Administrators has issued a similar decision.

Wisconsin Physicians Service Insurance Corporation: Transplant Genomics' TruGraf Blood Gene Expression Test**

The contractor has aligned its draft coverage terms with Palmetto’s draft LCD. The terms proposed to extend coverage for 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.

Wisconsin Physicians Service Insurance Corporation: 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, which aligns coverage terms with Palmetto’s earlier draft LCDs.

Final LCDs:

Noridian, CGS Administrators, and Wisconsin Physicians Service Insurance Corporation: Myriad Genetics’ myPath Melanoma**

The contractors aligned their coverage terms (see here, here, and here) with Palmetto’s earlier final coverage decision for myPath Melanoma. The 23-gene expression signature test helps doctors differentiate malignant from benign biopsies, these MACs will cover it for the "diagnosis or exclusion of melanoma" when a board-certified dermatopathologist orders it; when the biopsy can't be definitively classified as benign or malignant based on standard clinical and histopathological features; and when the patient has to endure another biopsy because of this uncertain classification.

Noridian and Wisconsin Physicians Service Insurance Corporation: Inivata's InVisionFirst-Lung**

The contractors have issued coverage decisions (see here and here) to align with Palmetto's final LCD on Inivata's InVisionFirst-Lung, a circulating tumor DNA next-gen sequencing test that assesses alterations in 36 genes. The test is intended to help doctors treat advanced non-small cell lung cancer patients. CGS Administrators issued a similar determination a few weeks ago.

 



**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.