By Kirell Lakhman
RedPath Integrated Pathology's tests for pancreatic cancer, cysts, and masses will be covered by Medicare in Pennsylvania, New Jersey, Maryland, Delaware, and Washington, DC, beginning Nov. 5.
The reimbursement decision, which covers RedPath's PathFinderTG technology for pancreatic cancer, cysts, and masses, was enabled by Medicare contract administrator and CMS contractor Highmark Medicare Services, which will also process the billing.
The decision was originally announced by HMS and ExonHit Therapeutics on Sept. 20 and 21, respectively, but did not mention the states involved. Paris-based ExonHit has a dog in the fight because in April it announced it plans to acquire RedPath for up to $32 million (see here and here).
Two months later, after RedPath told it HMS decided Medicare should no longer cover the PathFinderTG test pending a re-assessment, ExonHit put the deal on hold.
RedPath, which provides cancer diagnostics for pathologists, oncologists, surgeons, and other clinicians, had until July 9 to tell HMS why the test should continue to be covered. HMS, which planned to kill coverage Sept. 29, would then decide whether to change its mind.
Today, RedPath said Medicare has designated the DNA-based pathology technology as a “reasonable and necessary” service analyzing pancreatic cysts and masses "when traditional diagnostic evaluations are inconclusive."
Inconclusiveness could result from inconsistent or conflicting fluid chemistry testing, imaging studies, and cytology, or from indeterminate cytology results.
Performed in RedPath's Pittsburgh-based CLIA lab, PathFinderTG can also help MDs distinguish benign and malignant lesions and metastatic, synchronous, and recurrent tumors in breast, lung, liver, endometrial, and ovarian tissue. It can also be used to distinguish reactive and neoplastic lesions and to grade a lesion's dysplasia.
RedPath Chief Medical Officer Dennis Smith said the decision "will ensure continued access for Medicare patients … to this molecular … platform," adding that such technologies "are being increasingly used to make treatment decisions when traditional diagnostic tests provide inconclusive results.”