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

NEW YORK (GenomeWeb) – Medicare Administrative Contractor Noridian recently released a number of draft local coverage determinations (LCDs) to align its coverage terms for a variety of tests 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:

Noridian: 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 and Wisconsin Physicians Service Insurance Corporation Administrators have issued a similar decision (here and here).

Noridian: 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. Wisconsin Physicians Service Insurance Corporation has also aligned its coverage terms for this test with Palmetto.

Noridian: 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 has also aligned its draft coverage terms with Palmetto.

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

The contractor has aligned its draft coverage terms with Palmetto’s draft LCD. The terms propose 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 has also aligned its coverage terms with Palmetto.

Noridian: DermTech's Pigmented Lesion Assay**

The contractor has issued its draft coverage terms to align with Palmetto’s earlier proposed decision 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. Wisconsin Physicians Service Insurance Corporation and CGS have issued similar draft LCDs (see here and here).

**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.  

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