This is an excerpt from an 850-word article in the May 15, 2017, 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: There are few places and times where a broad cross-section of
There is a new development in one of the whistleblower lawsuits filed against several lab companies that offered specialty cardiology tests. Earlier this month, the Department of Justice announced a settlement with Quest Diagnostics involving its acquisition of Berkeley HeartLab, which was acquired by Quest in 2011. The DOJ said that Quest agreed to pay
CEO SUMMARY: Moving away from volume-based care will not be easy for clinical labs. After all, high volume sustains labs. But labs seeking to transition away from fee-for-service to value-based care must have a seat at the table where decisions are made, said a lab CEO who is part of Project Santa Fe, which wants
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for
AT LEAST 48 HOSPITALS, PHYSICIANS’ OFFICES, and ambulance companies in Britain’s National Health Service were among the many victims of a cyberattack Friday that affected tens of thousands of computers in as many as 150 countries, The New York Times reported. Hackers used malicious software developed by and stolen from the U.S. National Security Agency,
CEO SUMMARY: Among the major themes to emerge from the more than 60 sessions and 100 speakers at this year’s Executive War College on Lab and Pathology Management were the accelerating pace of integrated care, the growth of precision medicine, and use of big data to guide physicians. Other issues centered on labs’ need to
Theranos, Inc., is again in the news. On April 17, the company disclosed a global settlement with the federal Centers for Medicare & Medicaid Services (CMS) to resolve “all outstanding legal and regulatory proceedings between CMS and Theranos.” The company said, pursuant to terms of the settlement, CMS withdrew revocation of the company’s CLIA operating
CEO SUMMARY: Is it a new sign of the times? After decades of reluctance to sell their lab outreach businesses or enter into inpatient lab management agreements with commercial lab companies, a surprising number of hospitals and health systems are taking that step. Since the first of the year, sales of several major hospital lab
THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA.
The Diagnostic Accuracy and Innovation Act (DAIA) was made public