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
Add eight more laboratories to the list of lab companies whose patient data were breached when the American Medical Collection Agency was hacked. According to HealthITSecurity, in recent weeks, these labs reported breaches of their patient records:
American Esoteric Labs
South Texas Dermatopathology
Laboratory of Dermatopathology ADX
Another clinical laboratory company disclosed a major breach of its patients’ protected health information (PHI). On July 15, Clinical Pathology Laboratories (CPL), a division of Sonic Healthcare, issued a press release and disclosed that it estimated as many as 2.2 million of its patients may have had their data exposed in a breach at Retrieval Masters
Because of a $25 million grant from philanthropist Denny Sanford, the Veterans Administration and Sanford Health will provide free genetic testing to 250,000 veterans by 2022. These will be pharmacogenomic (PGx) tests designed to help VA physicians prescribe medication and dosages customized to the unique characteristics of individual patients. This innovative program was announced on Mar.
This is an excerpt from a 1,565-word article in the Feb.4 issue of THE DARK REPORT.
The full article is available to paid members of The Dark Intelligence Group.
CEO SUMMARY: With most hospitals now included as “applicable laboratories” in the PAMA Medicare price reporting guidelines and required to report their private payer lab test price data, this incisive
CEO SUMMARY: Will clinical labs heed the lessons learned from the first PAMA private payer market price reporting cycle that CMS conducted in 2017? One major difference is that the definition of applicable laboratories now includes most hospital labs. This creates the opportunity for a larger number of clinical labs to submit their price data
CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laboratories and anatomic pathology groups. What is more notable about these top
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