On September 8, 2016, the MolDX program at Medicare released a draft LCD providing coverage for the Veracyte PERCEPTA lung cancer test. The test is indicated for use when a patient has a suspicious lesion, bronchoscopy has been undertaken, and the results are ambiguous. The clinical scenario is similar to that of the Veracyte AFIRMA test, which is used in the face of an ambiguous FNA for a thyroid nodule.
The LCD was released via the Noridian contractor, which covers the Veracyte laboratory in California. However, some Medicare patients may be subject to hospital outpatient procedures, in which case the 14 day rule applies, and the test would be billed to Medicare by the hospital, putting the hospital in a pass-through billing relationship with Veracyte. Regional claims processing will be facilitated for these hospitals assuming all MolDX MACs (about 25 states) and then other MACs mirror the coverage.
The LCD is also a case study in modern MolDX LCD style, and should be used as a case study for anyone trying to understand the contractor's thinking on coverage analysis (for my deep dive, here.) The LCD is online at CMS, here (and in the cloud, here; DL368886.) Public comment is open until December 15, 2016. If you'd like to make your comment in person, Noridian holds a public meeting in Hawaii on Friday, October 7.
Veracyte issued a press release, here, and the story was covered at Genomeweb, here. As of September 13, a Veracyte investor webcast (from September 8) was still streaming online. A general deck by Veracyte for investors, updated to September 2016, is online here.