This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group.
CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In
CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory testing. One issue is how to educate physicians
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to certain medications. Some pathologists and lab executives have criticized the FDA’s actions
IT MAY NOT BE A COINCIDENCE THAT MANY RECENT NEWS CYCLES have more negative pathology news than positive pathology news. After all, laboratory medicine is at the core of most clinical care delivered to patients, so it’s no coincidence that pathology—both clinical and anatomic—is a prime target for government and private payers, along with federal investigators.
BeaconLBS announced a collaboration with MagnaCare of Garden City, N.Y., last month. The press release issued by the two companies stated that MagnaCare would use the “BeaconLBS Physician Decision Support (PDS) solution with its network of physician and laboratory providers.” MagnaCare describes itself as a company serving “Taft-Hartley funds, TPAs, carriers, and worker’s compensation and no-fault
Quest Diagnostics sold its clinical laboratory business in India last December, thus ending a 12-year effort to build a thriving business in that nation of 1.3 billion people. The buyer was Strand Life Sciences of Bengaluru, India. The transaction was announced in a press release issued by Quest Diagnostics and no purchase price was disclosed.
More than 63 healthcare and medical service organizations signed a letter asking officials at the federal Centers for Medicare and Medicaid Services (CMS) to reconsider their latest interpretation of a National Coverage Determination (NCD) on the subject of next-generation sequencing (NGS). Clinicalomics wrote that “the final NCD also included repeat testing when a new primary cancer
CEO SUMMARY: Since 2011, the University of Florida Health System has used pharmacogenetic test (PGx) results to guide physicians when they prescribe certain drugs. This initiative has improved patient outcomes, reduced the overall cost per episode of care, and gained partial reimbursement from health insurers for PGx test claims. As this testing becomes more widespread, clinical
CEO SUMMARY: When commercial and government payers use auditors to review a lab’s claims, they often use statistical sampling and extrapolation to limit the time needed to review claims. But proper sampling and extrapolation require following the rigorous scientific methods to produce a representative sample of claims to draw conclusions they can apply to the
CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery of its LIS and informatics specifically to enable