In the age of COVID-19, complying with the rigorous hygiene requirements CLIA, accreditation criteria, OSHA and other standards may not be enough. That’s because the U.S. Centers for Disease Control … [Read more...]
Labs in Court
A roundup of recent cases and enforcement actions involving the diagnostics industry
April 4, 2021
Theranos Redux? Feds Target New Silicon Valley Diagnostics Start-Up Investment Scam Case: Federal prosecutors have filed criminal charges against the co-founders of a San Francisco biotechnology … [Read more...]
Kickbacks
The HDL Saga Continues with $114 Million Verdict against Lab’s CEO and Marketing Principles
April 4, 2021
Health Diagnostics Laboratory, Inc. (HDL) has been gone for years but prosecution efforts targeting the massive kickback scandal it authored lives on. Naturally, the initial wave of actions targeted … [Read more...]
CMS
Price Transparency: 2 of 3 Hospitals Not Complying with New CMS Disclosure Rules, Study Finds
April 3, 2021
Despite vociferous industry protest, the Centers for Medicare and Medicaid Services’ (CMS’s) controversial new hospital price transparency rule officially took effect on Jan. 1, 2021. But through … [Read more...]
Compliance Perspectives
Medicare Medical Necessity Denials and How Your Lab Can Prevent Them
April 3, 2021
Ensuring that the lab services you bill for meet Medicare medical necessity requirements is one of the oldest challenges faced by lab compliance managers. And it doesn’t get any easier over time. The … [Read more...]
Compliance
Brief Your CEO: New OCR Data Shed Light on the Costs of Privacy Noncompliance
April 2, 2021
Getting lab officers to shell out money for compliance initiatives may be trickier when the penalties you’re trying to head off are for privacy violations. After all, HIPAA penalties tend to be fairly … [Read more...]
Labs In Court
Michigan Cardiologist Shells Out $2 Million to Settle False Billing Charges
April 2, 2021
Case: The feds claim that over an 11-year period the physician and his metropolitan Detroit area practice and lab sites violated the False Claims Act by billing Medicare, Medicaid and TRICARE for … [Read more...]
Labs in Court
Theranos Redux? Feds Target New Silicon Valley Diagnostics Start-Up Investment Scam
April 2, 2021
Case: Federal prosecutors have filed criminal charges against the co-founders of a San Francisco biotechnology start-up firm with defrauding investors by making bloated claims about a revolutionary … [Read more...]
Daily Update
Tests with EUA
April 2, 2021
COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test … [Read more...]
Labs In Court
Talking to Competing Lab Doesn’t Violate Marketing Manager’s Employment Contract
April 1, 2021
Case: In 2017, S&G lab hired a market manager at a base salary plus 35 percent of net profits generated by his accounts. But then came EKRA in 2018 and S&G felt compelled to redo the deal as a … [Read more...]
