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Local Coverage Determinations Roundup: Myriad, AltheaDx, Castle Bio, Razor Genomics, and More

NEW YORK – 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: MDxHealth's SelectMDx Prostate Cancer

The contractor has aligned its draft coverage terms with Palmetto's earlier proposed coverage decision for SelectMDx. The mRNA-based RT-PCR assay measures expression of HOXC6, DLX1, and KLK3 genes and is performed on a urine sample obtained after a digital rectal examination. Coverage of the test depends on certain criteria, such as if men have a PSA of 3ng/mL or greater, are able to tolerate a prostate biopsy, and can tolerate medical or surgical treatment for prostate cancer of Gleason Grade 2 or higher. 

Noridian: Myriad's GeneSight, AltheaDx's NeuroIDGenetix, and other combinatorial PGx panels for psychiatric illness

The contractor has issued a draft LCD for combinatorial PGx tests, including Genesight and NeuroIDGenetix, that gauge variants in two genes, CYP2C19 and CYP2D6, for patients with psychiatric illness. The draft policy aligns with Palmetto's proposed decision, which includes a list of the specific mental health drugs doctors must already be considering for a patient. 

Noridian also aligned its coverage criteria with a related draft policy from Palmetto outlining its broader coverage stance for PGx testing. 

Noridian: Natera's Signatera Minimal Residual Disease Testing for Colorectal Cancer

The contractor has issued draft coverage terms that align to Palmetto's draft LCD to cover Signetara, which gauges 16 SNPs in solid tumor tissue in patients with stage II/III colon cancer or patients with stage IIA rectal cancer. Both contractors will cover the tests for patients who currently don't have colorectal cancer but previously had stage II/III disease and are at risk for recurrence.

Noridian: Castle Biosciences' DecisionDx-Melanoma

The contractor has aligned its draft coverage terms with Palmetto's draft LCD to cover the melanoma test, which gauges the expression of 31 genes to determine a melanoma patient's risk of metastatic disease, for patients with cancers 0.3 mm or greater, or for those with smaller cancers when certain conditions are met. 

Noridian: Razor Genomics' Razor 14-Gene Lung Cancer Assay

The contractor has issued draft coverage terms that align to Palmetto's earlier decision to cover the Razor test when used as a predictive classifier for non-small cell lung cancer. The test must be ordered by a doctor for NSCLC patients with tumors smaller than 5 cm to be covered. 

Noridian: CareDx's AlloSure Kidney, Heart

The contractor has aligned its draft coverage terms with Palmetto's earlier LCDs for two indications of the AlloSure test, a non-invasive blood test that measures transplant injury via donor-derived cell-free DNA. The kidney test will be covered when it's used to help decide whether patients should have a renal biopsy two weeks after receiving a transplant organ. The heart test will be covered when it's used alongside the AlloMap test to assess risk of organ rejection in heart transplant patients and to determine if a heart biopsy is needed 55 days after transplant.  

Noridian: Kashi Clinical Laboratories' Molecular Microscope Diagnostic System and other kidney, heart biopsy tests for graft rejection

The contractor has issued draft coverage terms (see here and here) that align with two of Palmetto's draft LCDs to cover molecular diagnostic tests (see here and here) for kidney and heart transplant rejection. The contractors propose to specifically cover the microarray gene transcript assay Molecular Microscope Diagnostic System-Kidney for patients who have functioning renal allograft, don't require dialysis, and have received an allograft biopsy to assess rejection status. Similarly, the contractors are proposing to cover the MMDx-Heart test if certain conditions are met. 

**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.