By Joseph Burns, from the Volume XXV No. 7 – May 7, 2018 issue
CEO SUMMARY: In two separate lawsuits filed in April, UnitedHealthcare (UHC) and Anthem each charged that drug testing companies used pass-through-billing schemes in ways the insurers say are fraudulent. UHC filed its lawsuit on April 18. One day later, on April 19, Blue Cross and Blue Shield of Georgia and other Anthem companies filed suit
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 Jon Stone, from the Volume XXV No. 6 – April 16, 2018 issue
CEO SUMMARY: For many reasons, including cuts to lab test prices that health insurers pay, narrow networks, and more competition for lab test referrals, a significant number of lab companies are seeking ways to increase market share. These methods include the use of new laboratory test arrangements and innovative strategies for pricing lab tests. But
By Joseph Burns, from the Volume XXV No. 6 – April 16, 2018 issue
CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own request for summary judgment; and most recently ACLA filed its rebuttal to the
By R. Lewis Dark, from the Volume XXV No. 6 – April 16, 2018 issue
MOST PATHOLOGISTS WOULD AGREE THAT PATIENTS AND THEIR PHYSICIANS have every right to expect a timely, accurate lab test result. Stated differently, patients and physicians implicitly trust that a pathology laboratory in the United States will not make errors in specimen processing (technical component) and diagnosis (professional component).
For these reasons, the recent federal Centers for
This is an excerpt from a 2,920-word article in the March 26, 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: Here’s the first look for the lab industry at an important
By Joseph Burns, from the Volume XXV No. 5 – March 26, 2018 issue
MANY LAB EXECUTIVES were concerned last year after a judge in the District of Columbia Circuit Court ruled that clinical laboratories need to determine that all lab test services physicians order are medically necessary.
The court also ruled that ordering physicians do not need to determine medical necessity, noted the law firm McDonald Hopkins in a
By Joseph Burns, from the Volume XXV No. 5 – March 26, 2018 issue
CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access
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 Joseph Burns, from the Volume XXV No. 5 – March 26, 2018 issue
CEO SUMMARY: In an action against Theranos and two of its executives, the SEC said in a federal court filing this month that the company, CEO Elizabeth Holmes, and former COO Ramesh “Sunny” Balwani deceived investors into believing that the company’s portable blood analyzer could conduct comprehensive blood tests from drops of blood collected via
