By Joseph Burns, from the Volume XXV No. 6 – April 16, 2018 issue
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible
By Joseph Burns, from the Volume XXV No. 5 – March 26, 2018 issue
CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To do so, the agency would work with third parties, such as the
By Robert Michel, from the Volume XXV No. 4 – March 5, 2018 issue
CEO SUMMARY: Pass-through billing arrangements, particularly those involving clinical laboratory tests, have long been recognized by healthcare attorneys as having great potential to violate certain federal and state laws. Despite this fact, board members of a financially-struggling community hospital went forward with a pass-through billing agreement that news accounts says committed the hospital to pay
By Jon Stone, from the Volume XXV No. 3 – February 12, 2018 issue
CEO SUMMARY: Experts in lab compliance predict that clinical laboratories and anatomic pathology groups must anticipate tougher enforcement of federal and state laws this year. One source of increased compliance risk for lab companies is the rising use of third-party marketing agreements. David Gee, an experienced lab industry attorney at Davis Wright Tremaine, said lab
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.
CEO SUMMARY: UnitedHealth made national news when it filed a $100 million lawsuit against
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 legal proceedings involving the healthcare businesses some of the defendants have
By Joseph Burns, from the Volume XXV, No. 2 – January 22, 2018 issue
FOLLOWING YEARS OF CONTROVERSY associated with different plans to build a large new laboratory facility to serve Edmonton and the surrounding region, Alberta Health Services (AHS) will finance and build the new lab with its own resources.
Last month, the Alberta government announced that it will develop a new central laboratory that will process 80% of
By Robert Michel, from the Volume XXV, No. 1 – January 2, 2018 issue
In Arizona, individuals and patients who paid for clinical laboratory tests performed by Theranos, Inc., are finally getting refunds. These payments are a result of a settlement between the Arizona Attorney General and Theranos. News accounts indicate that, over the time in 2013 through 2016 that Theranos offered lab tests in Arizona through its relationship with
By Joseph Burns, from the Volume XXIV, No. 17 – December 11, 2017 issue
CEO SUMMARY: In September, Aetna filed a lawsuit in Pennsylvania accusing 14 defendants—including a hospital, a hospital management company, eight lab companies or lab management companies, two physicians, and two individuals—of defrauding Aetna, its client employers, and its members. The lawsuit is an example of a lab test arrangement in which independent lab companies and
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 Services will impose deep cuts to Part B
