TAG:
pharmacogenetic
November 4, 2019 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXVI No. 14 – October 14, 2019 Issue
Pharmacogenetic testing is gaining acceptance by a growing number of health insurers. On Oct. 1, UnitedHealthcare (UHC) began coverage of genetic tests that help physicians identify the anti-depressant drugs most likely to benefit their patients. UHC’s policy also extends coverage …
UTC Labs to Pay $41.6 Million in a Civil Settlement With DOJ
By Joseph Burns | From the Volume XXVI No. 15 – November 4, 2019 Issue
ONE MORE LAB COMPANY has settled allegations of fraud and abuse. Last month, UTC Laboratories agreed to pay a fine of $41.6 million and will be excluded from all federal healthcare programs for 25 years. Announced Oct. 9, the settlement resolves allegations that UTC violated the F…
PGx Testing Labs Concerned by FDA’s Statements, Actions
By Mary Van Doren | From the Volume XXVI No. 12 – September 3, 2019 Issue
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) ha…
Concerns Raised Over Pharmacogenetic Tests
By Joseph Burns | From the Volume XXVI No. 12 – September 3, 2019 Issue
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…
PGx Labs Concerned by FDA’s Statements, Actions
By Joseph Burns | From the Volume XXVI No. 12 – September 3, 2019 Issue
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 ce…
U of Florida Health Improves Patient Care with PGx Testing
By Joseph Burns | From the Volume XXV No. 17 – December 3, 2018 Issue
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 reimbursemen…
Allegations in UHC health insurance fraud case involve multiple defendants
By Mary Van Doren | From the Volume XXV No. 2 – January 22, 2018 Issue
This is an excerpt from a 5,000-word article in the January 22, 2018, 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. …
Allegations of Lab Test Fraud Involve Multiple Defendants
By Pamela Scherer McLeod | From the Volume XXV No. 2 – January 22, 2018 Issue
CEO SUMMARY: UnitedHealth made national news when it filed a $100 million lawsuit against Next Health and other defendants in Dallas in January 2017. The insurer alleged fraud involving clinical laboratory tests. That lawsuit is just the latest chapter in an almost decade-long string of …
In Florida, More Tests Added to UHC’s Decision-Support Program
By Joseph Burns | From the Volume XXV No. 1 – January 2, 2018 Issue
IN THE FIRST BROAD EXPANSION OF ITS pilot decision-support program for clinical lab testing in Florida, UnitedHealthcare (UHC) will add genetic and molecular tests, drug tests, and pathology procedures, among other assays starting in two months. On March 1, UHC will expand its labor…
TOP 10 LAB STORIES OF 2017
By Robert Michel | From the Volume XXIV No. 17 – December 11, 2017 Issue
1. CMS Sticks by Decision to Deeply Cut Medicare Part B Lab Test Fees SHORT OF A MIRACLE, the clinical laboratory industry is less than three weeks from the single most financially-disruptive event of the past 30 years. On Jan. 1, the federal Centers for Medicare and Medicaid Service…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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