The Centers for Medicare and Medicaid Services (CMS) has given the status of Advanced Diagnostic Laboratory Test (ADLT) to the Envisia Genomic Classifier, Veracyte’s genomic test specifically designed to facilitate the diagnosis of idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILDs).
The ADLT status, granted under the Protecting Access to Medicare Act of 2014 (PAMA), is given to innovative products that offer certain types of clinical information that cannot be obtained by any other means.
“We believe that attaining ADLT status for the Envisia classifier is important because it underscores the test’s novelty and value to patients, physicians and the healthcare system,” Bonnie Anderson, chairman and CEO of Veracyte, said in a press release.
“Importantly, we believe this milestone also helps position the Envisia classifier for reimbursement expansion as we move into 2021 and beyond,” Anderson said.
By gaining this status, Veracyte’s genomic test also will enter in a special market-based scheme that will be used to determine its final list price for patients with Medicare insurance.
During a period of six months starting on Oct. 1, Veracyte will collect information on private-payer payment rates for its test. The median value of these payment rates will then be used by the CMS to determine the test’s Medicare list price, which will be implemented July 1, 2021.
In the nine months preceding the adoption of the new list price, the Envisia Genomic Classifier will be reimbursed at a rate of $5,500 to all patients with Medicare insurance. This test was first covered by Medicare in 2019.
According to Veracyte, the Envisia Genomic Classifier is the first, and still the only, genomic test in the market that can be used to distinguish IPF from other ILDs, without requiring patients to undergo invasive, risky, and costly surgery.
By combining machine learning with RNA sequencing, the Envisia Genomic Classifier can scan patients’ genome to look for a pattern of genetic alterations associated with usual interstitial pneumonia (UIP), one of the key hallmarks of IPF. Of note, RNA are the molecules built from a gene’s DNA information that cells use as a template to make proteins; the genome refers to all genes present in human DNA.
This genomic diagnostic test may be particularly useful to help physicians identify IPF when radiological findings in high-resolution computed tomography lung scans are inconclusive.
It is estimated that each year up to 200,000 patients in the U.S. and Europe are evaluated for suspected ILDs, including IPF.
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