Business
Veracyte Receives ADLT Status for Envisia Genomic Classifier From Centers for Medicare and Medicaid Services
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) announced today that the Centers for Medicare and Medicaid Services (CMS) has
About this update from Veracyte, Inc.
[{"type":"text","content":" SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVeracyte, Inc. (Nasdaq: VCYT) announced today that the Centers for Medicare and Medicaid Services (CMS) has approved new Advanced Diagnostic Laboratory Test (ADLT) status for the Envisia® Genomic Classifier. The determination confirms that the Envisia classifier meets the criteria for ADLT status under the Protecting Access to Medicare Act of 2014 (PAMA), which is reserved for innovative products that provide novel clinical information that cannot be obtained by any other method. Veracyte’s Envisia classifier is the first and only genomic test that helps improve diagnosis of idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILDs).\n\nObtaining ADLT status initiates a specific, market-based approach to pricing the test for Medicare patients. For the six-month period beginning October 1, 2020 and ending March 31, 2021, Veracyte will collect private-payer payment rate data for the test, the median of which will be used by CMS to determine the Medicare pricing, beginning July 1, 2021. During the nine-month period prior to the new pricing, the Envisia classifier will be reimbursed at a rate of $5,500 for all Medicare patients. The Envisia classifier has been a covered benefit for Medicare patients since 2019.\n\n“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,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “Importantly, we believe this milestone also helps position the Envisia classifier for reimbursement expansion as we move into 2021 and beyond.”\n\nThe Envisia classifier is the first and only commercially available genomic test that helps distinguish IPF from other ILDs, without the need for risky surgery. The classifier enables physicians to more confidently diagnose IPF when results from HRCT imaging are not definitive. Veracyte developed the Envisia classifier by combining RNA whole-transcriptome sequencing and machine learning to enable the detection of a genomic pattern of usual interstitial pneumonia (UIP), whose presence is essential to IPF diagnosis.\n\nEach year in the United States and Europe, up to 200,000 patients are evaluated for suspected ILDs, including IPF, which is among the most common...