CMS coverage denial shutting down Predictive Biosciences

The decision by a CMS contractor to deny coverage for bladder cancer diagnostics from Predictive Biosciences Inc. (Lexington, Mass.) has caused the molecular diagnostic company to close its doors and lay off its 91 employees, CEO Pierre Cassigneul told BioCentury. He said the company is not viable in the absence of Medicare coverage, noting that Medicare represents about half of the market for Predictive's CertNDx bladder cancer diagnostic tests and many private payers mimic Medicare's coverage and reimbursement policies. Predictive's three bladder cancer tests are marketed in the U.S. as laboratory-developed tests, which are not subject to FDA approval.

In January, the Medicare contractor responsible for Ohio, where Predictive Bioscience's CLIA-certified laboratory is located, stopped paying claims for the company's tests, Cassigneul said. The contractor, CGS Administrators LLC, had previously been reimbursing about $380 per test. In April, CGS informed Predictive that resumption of coverage would be contingent on the company producing evidence of clinical utility, Cassigneul told BioCentury. He said a study to demonstrate the utility of CertNDx to predict bladder cancer recurrence could take two years to conduct, and "our investors are not willing to go further in supporting the company." CGS could not be reached for comment. ...