The Envisia Genomic Classifier test for idiopathic pulmonary fibrosis (IPF) diagnosis received a draft Medicare local coverage determination (LCD) through the MolDx (Molecular Diagnostics) service program, according to Veracyte. The decision is a key step in making the test widely available to patients, the company says.
LCDs are mandated by Medicare administrative contractors (MACs) and only applicable to their jurisdiction, which contrasts to national coverage determinations. They specify the clinical circumstances under which a service is considered reasonable and necessary, and assist providers in submitting claims for reimbursement.
To develop LCDs, MACs consider medical literature, the advice from medical societies and medical consultants, public comments, and comments from the provider community.
Specifically, the draft LCD was issued by WPS Health Solutions, but Veracyte expects three other MACs – CGS, Noridian Healthcare Solutions, and Palmetto GBA) that participate in the MolDx program to issue similar LCDs. The draft policy is now open for a 45-day comment period.
“We applaud the MolDx program for taking this important step to make the Envisia classifier widely available to Medicare patients,” Bonnie Anderson, Veracyte’s chairman and CEO, said in a press release. “The evidence supporting use of the Envisia classifier met MolDx’s high bar for coverage and strongly positions us to expand commercialization of the test in 2019.”
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Veracyte’s Envisia Classifier, designed to improve IPF diagnosis and help ensure appropriate treatment without requiring surgery, combines next-generation RNA sequencing and machine learning. It is the first IPF test achieving this Medicare coverage milestone, and will become the company’s third genomic test to gain Medicare coverage after Afirma for thyroid cancer (in 2012) and Percepta for lung cancer (in 2016).
According to Veracyte, up to 200,000 patients are evaluated each year for suspected interstitial lung diseases (ILDs) in the U.S. and Europe. IPF is one of the most common ILDs and also one of the most difficult to diagnose.
“Timely, accurate diagnosis of IPF is essential so that patients can receive optimal treatment,” said Fernando J. Martinez, MD, chief of the division of Pulmonary and Critical Care Medicine at Weill Cornell Medicine, and Veracyte’s scientific advisor. “IPF remains difficult to diagnose, with a challenge in distinguishing it from other interstitial lung diseases that can lead to diagnostic delay and, potentially, inappropriate therapy.”
The Envisia Classifier is used as a complement to high-resolution computed tomography (HRCT), routinely used with a clinical work-up to identify IPF.
Envisia evaluates patient samples collected through a non-surgical procedure called transbronchial biopsy. The test differentiates usual interstitial pneumonia (UIP), a typical diagnostic pattern for IPF, from non-UIP with high specificity and sensitivity.
In May 2018, Veracyte launched an Early Access Program to make the Envisia Genomic Classifier available to IPF patients around the country.