Congress Moves One Step Closer to Passing “Surprise Billing” Legislation

Prospects for the passage of legislation banning “surprise billing” of patients before the presidential election advanced significantly on Feb. 12 with the powerful House Ways and Committee … [Read more...]

Enforcement Trends: OCR Continues to Crack Down on HIPAA Right of Access Violations

On Sept. 9, 2019, the Office for Civil Rights (OCR), the HHS agency in charge of federal HIPAA enforcement, did something it had never done before by entering into a monetary settlement with a … [Read more...]

ACA Update: Uncertainty Will Continue as Supreme Court Passes Up Chance for a Quick Resolution

The agony of uncertainty over the fate of the Affordable Care Act will continue for at least another 12 months. The U.S. Supreme Court all but ensured that on Jan. 21, when it passed up the invitation … [Read more...]

HIPAA: OCR Clarifies Rules for Sharing Coronavirus Patient Medical Information During Current Health Emergency

The usual HIPAA Privacy restrictions on collecting, using and disclosing personal health information (PHI) are relaxed during public health emergencies. With this in mind, the Office for Civil Rights … [Read more...]

Labs In Court

Lab Gets Chance to Prove Fraud Claims against Software Vendor at Trial

Case: After being hit with a slew of CLIA penalties, a toxicology lab hired a software and IT services firm to help get its information systems back into compliance. But while progressing toward … [Read more...]

Labs in Court

Drug Abuse Treatment Owner Guilty of $57 Million Drug Test Pass-Thru Billing Conspiracy

Case: The owner of a northern Florida substance abuse treatment center pleaded guilty for his role in a $57 million pass-through lab testing billing and money laundering scheme. The way it worked: The … [Read more...]

FDA Watch

Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]

Industry Buzz

Lab Companies Scramble to Bring Coronavirus Detection Tests to Market

Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [Read more...]

Labs In Court

Lab Management Contract Dispute Must Go to Binding Arbitration

Case: A lab management services contract sent conflicting messages: Clause 32 said that all disputes under the contract would be resolved by binding arbitration; but Clause 7 said that all claims … [Read more...]


OIG Work Plan: Agency to Focus on Vaccine Adverse Event Reporting

The five new items the OIG added to its Work Plan have no direct impact on labs or lab services, although three of them might have an indirect effect on some labs. Here’s the rundown. CDC … [Read more...]