TAG:
anti kickback statute
First EKRA Guilty Plea Involves Lab Kickback
CEO SUMMARY: Federal investigators wasted little time in using the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) to prosecute fraud involving clinical laboratories and providers. The manager of an opioid treatment center in Kentucky pleaded guilty last month to three counts…
New Opioid Law Goes Beyond – Far Beyond – Anti-Kickback Statute
CEO SUMMARY: At the last minute, Congress added all clinical laboratories to a far-reaching provision in the newly-enacted …
Attorney Explains Risks from New ‘Support Act’
CEO SUMMARY: Legislation signed into law on Oct. 24 was designed to stem the nation’s opioid crisis. But in addition to applying to sober homes and addiction treatment centers, the law also applies to clinical laboratories. Called the ‘Support for Patients and Communities Act,’ the …
New Opioid Law Hits Labs Paying Sales Commissions
CEO SUMMARY: At the last minute, Congress added all clinical laboratories to a far-reaching anti-kickback provision in the newly-enacted Support for Patients and Communities Act. This provision applies to all payers, both government and private. Lab experts say this new law could have a n…
If 2019 Is a Tough Year, Blame Government, Payers
Traditionally, the new year is a time of optimism. People make resolutions such as exercising more and losing weight. Companies get to start the year with a fresh budget and the new opportunity to achieve their goals. Unfortunately, events of the last 90 days of this year are not auspicious for clin…
Defunct, Oft-Troubled Calloway Labs Hit with $1.4M Federal Judgement
HOW OFTEN IS A DEFUNCT LAB COMPANY IN THE NEWS? That was the odd development last week when it was announced that a U.S. District Court had entered a $1.4 million civil judgement against Calloway Laboratories, Inc., a toxicology lab company formerly based in Woburn, Mass., for busine…
Peeking at Whistleblower Claims: How Labs Induce Physicians
IN RECENT DECADES, probably no sector of the U.S. healthcare system has seen the level of fraud and abuse that seems to pervade the clinical laboratory industry. The common perception is that illegal inducements between lab companies and referring physicians are rampant and federal prosecutors have f…
June 18, 2018 Intelligence: Late Breaking Lab News
In New Jersey last week, David Nicoll, 44, the former owner of Biodiagnostic Laboratory Services (BLS) of Parsippany, N.J. was sentenced to 72 months in a federal prison. On the same day, his brother, Scott Nicoll, 37, who also worked at BLS, was sentenced to 43 months in prison. Bo…
Attorney Says Labs Face Increased Legal Liability
CEO SUMMARY: For many reasons, including cuts to lab test prices that health insurers pay, narrow networks, and more competition for lab test referrals, a significant number of lab companies are seeking ways to increase market share. These methods include the use of new laboratory test ar…
Anthem Seeks $13.5M from California Hospital
CEO SUMMARY: Anthem charged 37-bed Sonoma West Medical Center in Sebastopol, Calif., of engaging in an improper billing scheme to defraud Anthem and its affiliated Blue Cross and Blue Shield plans. In effect, the charge is a notification to SWMC that Anthem intends to sue SWMC and its…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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