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Local Coverage Determinations Roundup: Veracyte, Sonic Healthcare USA, Renalytix

NEW YORK – Medicare administrative contractors released final 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. 

Final LCDs: 

Although the below tests were mentioned in each of the LCDs, the MAC noted that those tests are not automatically covered under the final LCD. 

Palmetto: Veracyte's Afirma, Sonic Healthcare USA's ThyroSeq 

Palmetto released a final LCD consistent with its draft LCD covering molecular tests used for patients with an indeterminate or suspicious thyroid nodule under certain conditions, referencing Veracyte's Afirma Genomic Sequencing Classifier and Sonic Healthcare USA's ThyroSeq test in its decision. For these kinds of tests to be covered, the patient must not have been tested with the same or similar assay for the same clinical indication and must have either an indeterminate thyroid nodule as defined by Bethesda categories III or IV or a Bethesda category V nodule for which molecular testing can help further stratify the type of malignancy. 

If a patient has multiple nodules, concurrent or reflex testing may be medically necessary as long as the criteria are met, Palmetto said. 

The test results must be used to help in surgical decision-making after consideration of clinical, radiographic, and cytologic features. The patient must also be within the population and indication for which the test was developed. The performance of the test must be as good or better than currently covered services. 

Palmetto noted that next-generation sequencing tests used to identify genetic variants in malignant samples aren't within the scope of the LCD but may be covered under other existing policies. 

Noridian Healthcare Solutions and Wisconsin Physicians Service Insurance released final LCDs aligning with Palmetto's coverage. 

The LCDs will go into effect on July 28. 

National Government Services: Renalytix's KidneyIntelX and KidneyIntelX.dkd 

National Government Services released a final LCD this week aligned with its draft LCD covering Renalytix's KidneyIntelX and KidneyIntelX.dkd tests once in a patient's lifetime. The assays are covered if the results are used to facilitate therapeutic prognostic decision-making in the medical management of a selected patient population. They are also covered when the results are used to determine the risk of progressive decline in kidney function in patients older than 21 with type 2 diabetes and existing early-stage chronic kidney disease if the test is ordered by the treating physician or qualified nonphysician practitioner. 

The test must be performed in a CLIA-certified laboratory qualified to perform high-complexity testing, and the reason for the test must be documented by the treating practitioner and demonstrate that the test is medically reasonable and necessary. 

The assays are not covered for patients with estimated glomerular filtration rates lower than 30 or above 60 without albuminuria, patients with end-stage renal disease or those on renal recovery treatments, pregnant patients, patients who are currently hospitalized, or those taking etanercept. 

The tests are also not covered as screening or standalone diagnostics. 

The final LCD goes into effect on Aug. 1.