CEO SUMMARY: In 2014, during a ZPIC audit of an unnamed pharmacogenomic testing lab, a federal auditor reviewed a small number of claims that had been filed over a period of several years. Despite supporting letters from physicians, the auditor rejected those claims, then extrapolated the findings to declare payments for thousands of tests over
Tag: molecular diagnostic test
CEO SUMMARY: After Pharmacogenetics Diagnostic Laboratory LLC was audited by a Medicare Zone Program Integrity Contractor (ZPIC), it faced a $26 million repayment demand. The lab company appealed and asked for a redetermination, then filed for Chapter 11 bankruptcy protection. These developments should be a concern to all labs offering pharmacogenomic testing to Medicare patients.
This is an excerpt from a 1,340-word article in the January 9 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: Pharmacogenomic testing is expected to be a linchpin to the practice of precision
Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This rule would expand APRNs’ authority, currently limited to ordering and interpreting lab tests. In an
CEO SUMMARY: Many of the recently issued reimbursement rates for molecular diagnostic tests are inadequate and in fact are lower than the cost of running the tests, lab experts say. Smaller laboratories that specialize in developing and selling molecular tests could be forced to close. As many as 20 or more molecular labs operate in California
CEO SUMMARY: In a surprise move that further consolidates national anatomic pathology services, NeoGenomics will acquire Clarient Inc., from General Electric Healthcare. General Electric is getting cash, and preferred and common stock. The two companies announced plans to pursue integrated diagnostic services that would combine lab testing and diagnostic imaging data. The deal is subject
ANOTHER SIGN OF HEALTHCARE’S TRANSFORMATION came on June 1 when Sysmex Corporation of Kobe, Japan, and Laboratory Corporation of America in Burlington, North Carolina, announced a unique collaboration to develop blood-based molecular diagnostic tests for cancer.
The collaboration calls for Sysmex, a major in vitro diagnostics (IVD) manufacturer with expertise in hematology testing, to work with LabCorp. Efforts will center around two assays developed at Sysmex Inostics, called OncoBEAM and Plasma-Sequencing.
CEO SUMMARY: Prices recently established for molecular diagnostic tests are so low that they put patient access in jeopardy, declared a new lab industry coalition in a statement delivered to members of Congress. Called the Coalition to Strengthen the Future of Molecular Diagnostics, the organization also told members of Congress that—not only are the prices
It’s a laboratory acquisition that is worth US$1.3 billion. In Europe, Cinven, a private equity company, will acquire Labco SA of Paris, France. Labco operates medical laboratories in France, Spain, Italy, Portugal, Belgium, and the United Kingdom. It reports annual revenue of US$714 million, performs 150 million clinical laboratory tests yearly, and employs more than 6,000 people.
GeneCentric is a new lab testing company in Durham, North Carolina that was started by former executives of Laboratory Corporation of America. It intends to raise $20 million in a Series B capital offering. GeneCentric’s business model is to license molecular diagnostic tests, then develop the clinical trial data required to obtain coverage guidelines and