This month, there were seven new Work Plan items. Two of these, detailed below, may have implications for some labs. Opioid Use in Medicare Part D in 2018 Issue: The opioid crisis remains a public … [Read more...]
FDA
New FDA Guidance Tells IVD Makers How to Test for Biotin Interference
July 16, 2019
On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians … [Read more...]
FOCUS ON
New Project Aims to Provide Legal Guidance Needed to Do Business in Genomics
July 1, 2019
Technology changes faster than the laws designed to regulate it. Thus, while DNA testing has changed medicine and fueled growth in the lab industry, it has also created new legal challenges that few … [Read more...]
COMPLIANCE PLANS
OIG Monthly Work Plan Review: May 2019
May 23, 2019
Of the three new items in this month's OIG Work Plan items, one may have implications for some labs. Access to Medication-Assisted Treatment at Health Centers Issue: Medication-assisted … [Read more...]
FALSE CLAIMS
Chicago Doctor Indicted for Approving Medically Unnecessary In-Home Tests
February 1, 2019
Case: Working out of a Chicago-based clinic, a doctor allegedly prescribed and authorized ultrasounds, percutaneous allergen and nerve transmission for Medicare patients even though he knew the … [Read more...]
MARKETING
Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service
January 14, 2019
The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect 33 variants for multiple … [Read more...]
CONSUMER FRAUD
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
December 31, 2018
Molecular Lab Vigorously Denies But Pays $1.8 Million to Settle Fraud Charges Case: The feds claim that Molecular Testing Labs, a toxicology and genetics lab in Washington State, paid local labs … [Read more...]
CONSUMER FRAUD
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
November 28, 2018
New York Doctor Busted for Falsely Billing Medicaid for Lab Drug Tests Case: The State claims that the physician billed for $939,000 worth of drug testing services that his lab didn't and … [Read more...]
PATIENT SAFETY
Lab CEO Pleads Guilty to Distributing Medically Unnecessary Opioids
November 12, 2018
Case: The CEO of Tri-County Wellness Group and owner of labs and pain clinics in Michigan and Ohio, pleaded guilty to criminal charges for his role in $300 million health care fraud scheme involving … [Read more...]
PATIENT SAFETY
Diagnostics & Demographics: Is Your Lab Prepared to Accommodate an Aging Population?
November 5, 2018
Talk of an aging population isn't idle chatter. According to the U.S. Census Bureau, 2030 will mark a significant turning point in the nation's history. By then, all baby boomers will be older than … [Read more...]
