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...]
New Laws
January 1, 2021 Is D-Day for Hospital Pricing Transparency
September 3, 2020
It appears to be full speed ahead for hospital price transparency. The controversial effort to make hospitals divulge information about their healthcare pricing, including lab procedures, is very much … [Read more...]
Coronavirus
How Coronavirus Public Health Emergency Offers Potential for Temporary Stark Relief
March 25, 2020
On Jan. 31, 2020, the U.S. Department of Health and Human Services declared novel coronavirus, aka, COVID-19, a public health emergency (PHE). While it might sound like the highest level of government … [Read more...]
In Brief: OIG Opens Second Avenue for Anti-Kickback Statute Revisions
January 13, 2020
Even as we wait for the second draft of the proposed new value-based kickback relief rules—see National Intelligence Report (NIR), Nov. 15, 2019—the OIG issued its annual call for recommendations for … [Read more...]
NEWS
The Year in Labs Regulation: The 6 Biggest Stories of 2019
January 2, 2020
"May you live in interesting times.” This ancient Chinese curse extolling the virtues of stability may resonate with those of you who work in the lab industry and have a stake in federal … [Read more...]
COMPLIANCE GUIDANCE
Stark Law: CMS Plan Would Make It Easier for Labs to Get Advisory Opinions
September 9, 2019
In late July, CMS proposed to update the advisory opinion process that labs and other providers use to get a determination about whether a proposed business arrangement would violate the Stark Law. … [Read more...]
