Electronic Health Records: The eClinicalWorks False Claims Settlement—Big Fines & Unprecedented CIA Obligations

False Claims Act actions targeting health care vendors have become more common. eClinicalWorks (ECW), one country's biggest electronic health records software vendors, learned that lesson the hard way … [Read more...]

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Quest Fined for Self-Disclosed Violations for Second Time in 2017. Case: Quest Diagnostics, Inc., New Jersey agreed to pay over $1.151 million for three Civil Monetary Penalties Law … [Read more...]


Notorious File: Feds Take Down Three More Doctors in BLS Lab Bribery Scheme

The Biodiagnostic Laboratory Service (BLS) case continues to be the poster child for the evils of fraud and greed in the health care industry, generating record numbers of prosecutions against medical … [Read more...]


Reimbursement Trends: 5 More New Molecular Tests Get the Medicare Green Light from Palmetto

Normally among the slowest payors to accept promising but unproven new tests, Medicare continues to loosen the reins for molecular assays. In May, Palmetto GBA (Columbia, SC), one of Medicare's most … [Read more...]


Enforcement Trends: Labs Get Cameo, Rather than Starring Role in OIG’s New Enforcement Report

The Office of Inspector General just published its Semiannual Report to Congress (covering Oct. 1, 2016 through March 31, 2017). It's mostly more of the same other than the fact that, for once, … [Read more...]


Compliance Scorecard: Significant New HIPAA Fines

Health data and information security figured prominently in May enforcement activity. In addition to the blockbuster eClinicalWorks EHR software settlement discussed on page 3, there was an unusually … [Read more...]


Medical Necessity Requirement Bites Anatomic Pathologists

By Robert Mazer  bio The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains. Medicare permits a pathologist to order special stains when … [Read more...]


FDA Sends 14 Warning Letters Regarding Cancer Products

The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients … [Read more...]


Another Decision in the HDL Case Highlights Kickback Risks of Patient Responsibility Waivers Involving Private Payers

The Health Diagnostics Laboratory, Inc. (HDL) and Singulex saga continues. The latest chapter involves not the labs themselves but BlueWave Healthcare Consultants, their marketing firm. And it raises … [Read more...]


Theranos Announces Settlement Agreements with CMS and Arizona Attorney General

After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to … [Read more...]