CEO SUMMARY: On Nov. 2, the federal Centers for Medicare and Medicaid Services released its Physician Fee Schedule for 2019. It says it will expand the number of labs from which it collects data about the lab test prices paid by private health insurers. While some labs may welcome these changes, groups representing clinical laboratories
There is an important new development in the lawsuit in federal court that challenges how the Department of Health and Human Services (HHS) is implementing the Protecting Access to Medicare Act of 2014 (PAMA). An appeal was filed by attorneys representing the American Clinical Laboratory Association (ACLA).
On Friday, Oct. 19, the ACLA’s lead attorney on the case, Mark D.
IN RECENT DECADES, probably no sector of the U.S. healthcare system has seen the level of fraud and abuse that seems to pervade the clinical laboratory industry. The common perception is that illegal inducements between lab companies and referring physicians are rampant and federal prosecutors have failed to bring enough violators to justice to effectively
Every pathologist and clinical lab administrator should pay attention to two federal court decisions made recently in two different legal cases. One decision is bad news for the entire clinical lab industry. The other is bad news for lab companies that push compliance with federal anti-kickback laws.
The most important court decision came in the American
News that a laboratory’s courier truck was high-jacked in broad daylight with patient specimens aboard puts the spotlight on whether the security practices labs use to protect drivers, vehicles, and the patient specimens they may be carrying are adequate. On Aug. 3 in Durham, N.C., a driver of a courier vehicle owned by Laboratory Corporation of
There is a new sector in the clinical laboratory industry. It is called “global direct-to-consumer (DTC) genetic health testing” by Kalorama Information, a market research firm based in Rockville, Md. In a recent report, Kalorama says this sector is comprised of the direct-to-consumer genetic tests which are initiated by the consumer, meaning that the consumer decides
CEO SUMMARY: Reporting in The Wall Street Journal shows that some physicians in Arizona were concerned about the harm from erroneous test results from Theranos Inc. But those physicians who expressed concern may have been only a small set of the number of physicians who were worried about patient harm. After reviewing the concerns about
CEO SUMMARY: While Theranos was a darling of the business and national media, Wall Street Journal reporter John Carreyrou was hearing troubling reports about patients who got incongruent lab results that put them at risk for inappropriate medical treatments. His investigation of Theranos and its celebrated founder, Elizabeth Holmes, revealed that the company’s much-touted lab
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