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...]
FOCUS ON
The Year in Labs Regulation: The 9 Biggest Stories of 2020
December 20, 2020
When 2020 started, COVID-19 was just a news story unfolding on the other side of the globe in China. The novelty of the pathogen meant that there were no tests specifically targeting the virus on the … [Read more...]
Special Report
Final Rules Offer Real Stark and Kickback Relief but Largely Exclude Labs
With its time apparently running out, the Trump administration completed one of its pet projects by finalizing the kickback reform rules it proposed in October 2019. Issued on Nov. 20, the new final … [Read more...]
Labs In Court
A roundup of recent cases and enforcement actions involving the diagnostics industry
November 2, 2020
Michigan Reference Lab Settles False Billing Charges for $1.2 Million Case: The OIG claimed that Michigan reference lab Great Lakes Medical Laboratory, Inc. ripped off Medicare and United Mine … [Read more...]
Whistleblowers
California Case Shows Why Paying Specimen Collection Fees of Any Amount Are a Liability Risk
September 17, 2020
Paying physicians fees to collect and process patient samples for testing is a dicey proposition because it exposes labs to suspicion under the Stark and Anti-Kickback Statute laws. Such arrangements … [Read more...]
Labs In Court
NIPT Lab Company Pays $49 Million to Settle False Billing and Kickback Charges
September 11, 2020
Case: A month after going public, Progenity agreed to shell out $49 million to settle claims of overbilling and paying physicians kickbacks to order its noninvasive prenatal tests (NIPT). The case, … [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...]
Labs In Court
A roundup of recent cases and enforcement actions involving the diagnostics industry
September 4, 2020
NIPT Lab Company Pays $49 Million to Settle False Billing and Kickback Charges Case: A month after going public, Progenity agreed to shell out $49 million to settle claims of overbilling and … [Read more...]
In the News
Healthcare Organizations Call for Quick Action on Kickback Law Changes
September 3, 2020
Labs and the health industry have been waiting for years for some Stark Law and Anti-Kickback Statute (AKS) relief. Last October, HHS, CMS and the OIG finally unveiled the long-awaited plans to … [Read more...]
Labs In Court
A roundup of recent cases and enforcement actions involving the diagnostics industry
June 3, 2020
Whistleblower Lawsuit Can’t Start Until Criminal Investigation Ends Case: Two former MedComp Laboratory Sciences employees filed a whistleblower lawsuit accusing the lab of concocting an elaborate … [Read more...]
