Global News

EU Shuffles IVDR Implementation Plan but Sticks to May 2022 D-Day

As you may know if your lab does business in Europe, the European Union (EU) has been planning to implement an ambitious new device regulation called the In Vitro Diagnostic Regulation (IVDR). Those … [Read more...]

Reimbursement

MCIT Medicare Coverage Rule Could Be Reimbursement “Breakthrough” for Makers of LDTs

Medical device makers and members of Congress are growing impatient as CMS sends signals of still further delay on a final decision on a final rule that would automatically provide initial Medicare … [Read more...]

Compliance

New Laws: New HHS Policy Makes Labs Potentially Liable for LGBTQ Discrimination

While it doesn’t directly relate to billing and reimbursement, federal civil rights laws have an impact on certain aspects of lab operations. These laws ban your lab from discriminating on the basis … [Read more...]

False Claims

Federal Court Nixes Appeal of Physician Convicted of Participating in Urine Drug Test Billing Scam

Before the pandemic began, fraudulent utilization and false billing of medically unnecessary urine drug screening had climbed to the top of the agenda for federal enforcement. (See National Lab … [Read more...]

Compliance

Brief Your CEO: New OCR Data Shed Light on the Costs of Privacy Noncompliance

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...]

Special Report: Long-Awaited Kickback Relief Rules Leave Labs Out in the Cold

The final rule for value-based care kickback relief that HHS and the OIG published on Nov. 20 is slightly more favorable to labs than the proposed rule published in October 2019. But with a limited … [Read more...]

Whistleblowers:

Lab that Ignores Employee’s Billing Concerns Settles FCA Case for $43 Million

One of the costliest False Claims Act settlements involving lab tests in recent years is still one more cautionary tale of how dismissing the reports of lab employees who come forward to express … [Read more...]

Enforcement Trends

Feds Bust Labs for Telemedicine Testing Scams

So much for the pandemic’s dulling the momentum of federal fraud enforcement. Dubbed “Operation Rubber Stamp,” the new nationwide enforcement action revealed by the Department of Justice (DOJ) on … [Read more...]

False Claims Act

Federal Appeals Court Tosses Cold Water on DOJ’s Crackdown on Weak Whistleblower Suits

It’s fair to say that when it comes to False Claims Act (FCA) whistleblower qui tam lawsuits, the current U.S. Department of Justice (DOJ) is less enthusiastic than its predecessor. In fact, the DOJ … [Read more...]

Stark Law

CMS Proposes to Peel Back Restrictions on Physician Owned Hospital Expansions

From the onset, the Administration has assigned a high priority to loosening Stark Law and Anti-Kickback Statute (AKS) restrictions. And now CMS has floated two new proposals allowing for greater … [Read more...]


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