TAG:
genetic testing
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…
Labs Get High Denial Rates Under New NCCI Rules
By Joseph Burns | From the Volume XXVI No. 6 – April 29, 2019 Issue
CEO SUMMARY: Under guidelines the National Correct Coding Initiative issued last year, many clinical laboratories are not getting paid for some tests. The rates of denial for labs running mostly molecular tests could range from 40% to 100% of revenue, one billing expert said. Implemented …
Nine Lab Groups Say New NCCI Policy Is Inconsistent
By Joseph Burns | From the Volume XXVI No. 5 – April 8, 2019 Issue
CEO SUMMARY: By its name alone, the National Correct Coding Initiative (NCCI) Policy Manual implies that it will be accurate and consistent with other coding initiatives. But nine groups representing various clinical laboratories say NCCI guidelines that the federal Centers for Medicare a…
March 18, 2019 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXVI No. 4 – March 18, 2019 Issue
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 medicat…
January 14, 2019 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXVI No. 1 – January 14, 2019 Issue
Up to 10,000 patients will get free genetic testing at Northwell Health, the nation’s largest urban health network. In a deal announced on Jan. 9, Northwell Health and Color, a genetic testing company, will collaborate on a program to offer geneti…
Several Big Surprises in 2018’s Top 10 Lab Stories
By Robert Michel | From the Volume XXV No. 18 – December 24, 2018 Issue
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 laborator…
Biggest IVD Manufacturers Report Robust Third Quarter Earnings
By Robert Michel | From the Volume XXV No. 15 – October 22, 2018 Issue
In a time of shrinking lab budgets and falling prices for lab tests in the United States, how are the larger in vitro diagnostic (IVD) manufacturers doing? A look at third-quarter financial reports provides useful insights as to which segments within the IVD industry are doing better than ot…
Under Audit, Labs Need Statistics on Their Side
By Joseph Burns | From the Volume XXV No. 13 – September 10, 2018 Issue
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…
More Primary Care Docs Will Offer Genetic Tests
By Robert Michel | From the Volume XXV No. 10 – July 9, 2018 Issue
CEO SUMMARY: This summer, both Geisinger Health and Sanford Health will introduce genetic tests designed specifically for use by primary care physicians in their daily practice. This is a significant milestone on the road to wider deployment of precision medicine services. In the case of …
Theranos News Gets Worse for the Former Silicon Valley Hero
By R. Lewis Dark | From the Volume XXV No. 9 – June 18, 2018 Issue
CEO SUMMARY: In a tale of two fraudsters, the Department of Justice has filed a warning shot to all technology startups: Criminal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani could mean prison time and massive fines. In this latest Theranos news, The DOJ ci…
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Volume XXXI, No. 6 – April 29, 2024
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