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Local Coverage Determinations Roundup: MDxHealth, Myriad, AltheaDx, Natera, and More

NEW YORK – Medicare Administrative Contractor Palmetto 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.


Draft LCDs: 

Palmetto: MDxHealth's SelectMDx Prostate Cancer

The contractor has proposed to cover the prostate cancer aggressiveness test in men if they meet certain criteria. For example, they must have a PSA of 3 ng/mL or greater, they must be able to tolerate a prostate biopsy, and tolerate medical or surgical treatment for prostate cancer of Gleason Grade 2 or higher. SelectMDx is an mRNA-based RT-PCR assay that measures expression of HOXC6, DLX1, and KLK3 genes and is performed on urine obtained after a digital rectal examination. 

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

The contractor revised an earlier coverage decision, entitled "GeneSight Assay for Refractory Depression," with a new draft document, entitled "MolDx: Combinatorial Pharmacogenomics Limited Coverage." According to Palmetto, it decided to update coverage criteria for this policy based on a review of new evidence and added coverage indications to include Althea's and other molecular tests.  

In the updated document, the contractor has proposed to cover combinatorial PGx tests, such as GeneSight and NeuroIDGenetix, that gauge variants in two genes, CYP2C19 and CYP2D6, for individuals with psychiatric illness. The document includes a list of the specific mental health or depression drugs that the doctor must be already considering for a patient based on the Clinical Pharmacogenetics Implementation Consortium's recommendations. 

In another draft coverage policy, entitled "Pharmacogenomics testing," Palmetto elaborated its coverage stance for PGx testing that would broadly apply to all uses of PGx testing, including when performed on patients with psychiatric and neurologic conditions. The draft policy notes that PGx testing is reasonable and necessary to help doctors pick a medication for patients once they've already narrowed down the options based on other clinical considerations, scientific information, their own professional judgment, and their patients' specific diagnosis. The medical record must reflect that the doctor has considered "non-genetic factors to make a preliminary prescribing decision." 

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

The contractor has proposed to cover Signatara to gauge 16 SNPs in solid tumor tissue and then find these mutations in blood samples from patients with stage II/III colon cancer or patients with stage IIA rectal cancer. Palmetto is also willing to 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. In this latter setting, the test is used to detect the presence of clonal DNA in blood. 

Palmetto: Castle Biosciences' DecisionDx-Melanoma

The contractor has proposed to cover the 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. The draft policy notes that the test is not covered for patients with distant, metastatic cutaneous melanoma and those not considering treatment for the disease. Palmetto issued the draft document in response to a reconsideration request to expand the indication of the test, and as a result, modified the coverage information, as well as the summary and analysis of evidence. 

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

The contractor proposed coverage for the Razor test when used as a predictive classifier for non-small cell lung cancer. In order to garner coverage, the test must be ordered by a doctor for NSCLC patients with tumors smaller than 5 cm. The patient's cancer cannot have spread to the lymph nodes, the patient must be able to tolerate chemotherapy, and the clinician should be considering adjuvant treatment with platinum-based chemo.

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

The contractor has proposed in two separate policies (see here and here) to cover molecular diagnostic tests for kidney and heart transplant rejection. The microarray gene transcript assay Molecular Microscope Diagnostic System-Kidney is for patients who have functioning renal allograft, don’t require dialysis, and have received an allograft biopsy to assess rejection status. Before performing the MDx test, it must be unclear whether the patient is undergoing rejection based on histologic, immunohistologic, and serologic assessments. The molecular test must be performed of tissue from allograft biopsy, and must be ordered by the pathologist interpreting the biopsy or a doctor who is part of the patient’s transplant team. Similarly, the contractor is proposing to cover the MMDx-Heart test if certain conditions are met.