WITH EACH NEW RULING about coverage for a proprietary diagnostic assay, Medicare officials send a message to the entire clinical laboratory industry that any lab company with a proprietary test needs to submit adequate clinical evidence that demonstrates two positive aspects of the test.
First, that the assay accurately measures the biomarkers that it says it
PAML of Spokane, Washington, was the subject of an unusual public disclosure recently made by Laboratory Corporation of America. The lab company sent a statement to the Spokane Journal of Business stating its plans to make PAML “its primary lab site in the western U.S. for workplace and toxicology testing.” The statement was made to the
Here’s an update on Theranos, the troubled lab company that is struggling to stay alive. Once again, reporter John Carreyrou of The Wall Street Journal scooped his peers by reporting that Theranos has listed its corporate offices for lease. For lab companies shopping for office space in Palo Alto, Calif., Theranos has listed its 116,172 square
Theranos is back in the news again. The Wall Street Journal reported earlier this month that the troubled lab company is close to negotiating a settlement with Walgreens after being sued for $140 million in a breach of contract lawsuit filed by the national pharmacy chain. According to the journal, the settlement amount may be as
CEO SUMMARY: It’s becoming a familiar story. In Houston, a pharmacogenomics lab company started strong in 2011, then payments dropped sharply when Medicare issued restrictive new guidelines for PGx testing. Next, the Medicare administrative contractor handling the claims of CompanionDx Reference Lab canceled the lab’s registry and stopped paying most Medicare claims. In the wake
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
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
CEO SUMMARY: In recent years, insurers have raised the bar and become much tougher when making coverage and reimbursement decisions for molecular assays, genomic, and genetic tests. Yet several lab testing companies are having good success at demonstrating the validity and clinical utility of their assays. Among them is Foundation Medicine, of Cambridge, Mass. In
PRIVATE PAYERS AND MEDICARE contractors are taking divergent approaches to establishing coverage policies and setting prices for molecular and genetic tests. That’s what Kuo Bianchini Tong, MS, CEO of Quorum Consulting Inc., sees happening.
“One approach seeks to recognize the clinical utility and value of these tests with nuanced, more discreet coding and pricing,” he observed.