Daily Update

Tests with EUA

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

NIPT Lab Company Pays $49 Million to Settle False Billing and Kickback Charges

Case: A month after going public, Progenity agreed to shell out $49 million to settle claims of overbilling and paying physicians kickbacks to order its noninvasive prenatal tests (NIPT). The case, … [Read more...]

FDA Watch

Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs

The COVID-19 pandemic has exposed how the FDA’s makeshift premarket control over laboratory developed tests (LDTs) stifles innovation and keeps desperately needed new tests from reaching the market. … [Read more...]

Tool

Telecommuter Home Office Hazard Assessment & Inspection Checklist

While not an OSHA obligation, it’s highly advisable to take measures to protect the health and safety of telecommuting lab employees who work from home. How? By having employees seeking approval to … [Read more...]

Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

NIPT Lab Company Pays $49 Million to Settle False Billing and Kickback Charges Case: A month after going public, Progenity agreed to shell out $49 million to settle claims of overbilling and … [Read more...]

Quiz

Can Racial Discrimination Be Proven with Circumstantial Evidence Alone? 

SITUATION An equipment repair technician who also happens to be the lab’s only African American employee endures racial abuse at the hands of his supervisor and co-workers. He complains to … [Read more...]

In the News

Healthcare Organizations Call for Quick Action on Kickback Law Changes

Labs and the health industry have been waiting for years for some Stark Law and Anti-Kickback Statute (AKS) relief. Last October, HHS, CMS and the OIG finally unveiled the long-awaited plans to … [Read more...]

Labs In Court

Whistleblower Can Sue Lab for Alleged Specimen Fee Kickback Collection Ripoff

Case: A whistleblower filed a False Claims Act suit charging a California lab of entering into “sham phlebotomy contracts” paying kickbacks to physicians’ family members and staff in the form of … [Read more...]

Lab Compliance Advisor Newsletter Archive

By clicking on any of the links below you agree that you are the the only person who is accessing your single user LCA subscription license and that you are not sharing your username and password with … [Read more...]

Current Issue of LCA

Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download LCA content: I agree that I am the the only person who is accessing my … [Read more...]


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