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
May 19, 2021
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
May 19, 2021
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
May 10, 2021
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
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...]
Special Report: Long-Awaited Kickback Relief Rules Leave Labs Out in the Cold
December 20, 2020
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
November 17, 2020
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
November 17, 2020
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
September 4, 2020
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
September 4, 2020
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...]
