How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Essential
Subscribe today for access to
Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
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.
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.
Medicaid Fraud Recoveries Drop Significantly in 2022
At $1.1 billion, total recoveries in 2022 did exceed $1 billion for the fourth year in a row, but dropped from $1.7 billion in FY 2021
Congress Offers New Hopes of PAMA Reform
On March 28, the 118th Congress raised lab industry hopes once more by reintroducing the Saving Access to Laboratory Services Act (SALSA).
OIG OKs Offering Patients Gift Cards for Returning At-Home Test Kits
A new OIG Advisory Opinion sheds some light on when it’s permissible for a lab to offer customers a gift card for returning their at-home testing kit.
SCOTUS to Decide Monumental Question Affecting Providers’ FCA Liability
It’s not just billions of dollars on the line, but the very future of whistleblower lawsuits and FCA enforcement.
FCA Enforcement Activity Is Up but Recovery Dollars Are Down
The DOJ’s recent report on FCA enforcement statistics for FY 2022 shows that while actions are dramatically up, recoveries are way down.
