Compliance Trends

Labs Using New Legal Defense to Shoot Down FCA Lawsuits Over Unclear Regulations

Although the deliberate offenders tend to get all of the attention, many if not most billing, coding and reimbursement violations are committed by labs that want to comply with the rules but find them … [Read more...]

Compliance Alert

OIG Calls on CMS to Recover Phlebotomy Travel Allowance Overpayments

If your lab bills Medicare for phlebotomy travel allowances, a Medicare Administrative Contractor (MAC) claims audit may be in your future. The threat stems from a new Office of Inspector General … [Read more...]

Compliance Alert

OSHA Orders Inspectors to Use the Hammer to Enforce New COVID-19 Protocols

On June 21, OSHA issued a new Emergency Temporary Standard (ETS) requiring labs, hospitals and other providers to take extensive measures to protect frontline workers against risk of COVID-19 … [Read more...]

Enforcement Trends

Federal False Claims Act Recoveries Hit 5-Year High

For more than a decade, enforcement of the federal false claims act was a government cash cow. But in recent years, investment returns on the activity actually declined. That trend came to an end last … [Read more...]

Kickbacks

OIG Sheds Light on When Price Reductions Must Meet Discounts Safe Harbor

Labs that offer discounts of any kind to referring physicians run the risk of liability under the Anti-Kickback Statute (AKS) and other federal laws. However, new OIG Advisory Opinion No. 21-06 gives … [Read more...]

Labs in Court

University of Miami Settles Lab Testing False Claim Charges for $22 Million

Case: In this particular case, “The U” stands for unnecessary, as in medically unnecessary lab tests billed to Medicare by the University of Miami’s lab and off campus hospital-based facilities. The … [Read more...]

Labs in Court

Texas Provider Pays $214K for Violating Federal COVID-19 Workplace Protocols

Case: In what appears to be a first, the Texas parent of an Iowa nursing home has agreed to repay $214,200 in federal monies for not following COVID-19 safety protocols during an outbreak at the … [Read more...]

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...]


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