Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Quiz: Is This Illegal Remuneration Under the AKS?
A recent court case sheds some light on if denying employment can count as illegal remuneration under the Anti-Kickback Statute.
Labs in Court: Lab Settles Kickback Allegations for $5.9M
Two companies settle kickback and FCA-related claims, a qui tam case is tossed, and a lab tech loses a workplace harassment case.
Urine Drug & Genetic Testing Remain Top Enforcement Targets
In an analysis of enforcement actions from the end of 2022 to early spring 2023, cases involving urine drug testing were the most prevalent.
How to Perform a Billing, Coding, & Reimbursement Process Compliance Audit
Auditing in medical laboratories is critical for reviewing processes to identify erroneous outcomes, as well as areas for improvement.
How Can Labs Attract Top Talent In a Tough Economy?
This Lab Institute session will share how lab leaders can gain an advantage in today's tight pathology job market.
ACMG Statements Highlight Ongoing Concerns around Polygenic Risk Scores
Though there are currently no clinical guidelines for their use, PRSs are being widely used in health care.
Compliance Tool: Model Whistleblower Protection Policy
This model can help you create a whistleblower protection policy for your lab to encourage employees to voice their compliance concerns.
Turning Whistleblower Lemons into Compliance Lemonade
A False Claims Act whistleblower lawsuit can do significant damage to your lab and its reputation, even if the case lacks truth and merit.
FDA to Hold Off on Enforcing New Medical Device Cybersecurity Requirements
Although the law officially took effect on March 29, the FDA says it isn’t planning to enforce the new rules until October 1.
Lab Owner Charged in Latest COVID-19 Fraud Crackdown
In the latest major COVID-19-related enforcement action, 18 individuals were charged in various schemes worth more than $490 million.
