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) has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In
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 certain medications. Some pathologists and lab executives have criticized the FDA’s actions
By Robert Michel, from the Volume XXVI No. 7 – May 20, 2019 issue
CEO SUMMARY: There was an interesting consensus that emerged from the 80 sessions and 118 speakers at this year’s Executive War College in New Orleans earlier this month. The consensus centered around two themes. One theme is disruption, which is bad news for those labs that hope to maintain the status quo. The other theme
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 and Medicaid Services issued in December and implemented on Jan. 1 are inconsistent
By Joseph Burns, from the Volume XXVI No. 2 – February 4, 2019 issue
WITH EACH NEW RULING about coverage for a proprietary diagnostic assay, Medicare officials send a message to the entire clinical laboratory industry that any lab company with a proprietary test needs to submit adequate clinical evidence that demonstrates two positive aspects of the test.
First, that the assay accurately measures the biomarkers that it says it
By Joseph Burns, from the Volume XXVI No. 2 – February 4, 2019 issue
CEO SUMMARY: It is ironic that, after the federal Centers for Medicare and Medicaid Services (CMS) enacted the deepest price cuts to the Part B Clinical Laboratory Fee Schedule in more than 50 years, a U.S. Senator now asks CMS why it will pay billions more for lab testing. The question from Iowa Senator Chuck
By Mary Van Doren, from the Volume XXVI No. 1 – January 14, 2019 issue
CEO SUMMARY: This will be one of the most challenging years facing the clinical lab industry since the early 1990s. The CMS scheme to collect private payer lab test prices and use that data to set Medicare clinical laboratory test prices is proving to be an indiscriminate tool that is poised to undermine the financial integrity of many labs,
By R. Lewis Dark, from the Volume XXVI No. 1 – January 14, 2019 issue
It may be timely to ask a provocative question that touches everyone in the profession of laboratory medicine. Is there a future for community laboratories and hospital lab outreach programs in the United States, given the different forces acting upon the clinical laboratory industry today?
In this issue, our editorial team describes the multiple disruptive consequences
By R. Lewis Dark, from the Volume XXV No. 18 – December 24, 2018 issue
Each time a new year approaches, it is natural to look ahead and think about what the next 12 months will bring. My bet is that certain sectors of the clinical laboratory industry are soon to experience substantial disruption.
This disruption will come in two forms. First, federal regulators will be tougher on labs that violate
By Robert Michel, from the Volume XXV No. 17 – December 3, 2018 issue
IN RECENT DAYS, RUMORS HAVE SURFACED that UnitedHealthcare has begun to terminate the contracts it holds with a number of regional and non-national clinical laboratories.
This news surfaced just as The Dark Report went to press. Given its importance to the clinical laboratory industry, we wanted to alert lab executives and pathologists to this development as
