LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Enforcement-nir
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Articles and Reports
Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments
Inadequate CMS oversight resulted in $888.2 million in improper payments for the highest reimbursing molecular pathology genetic tests, report says.
Enforcement Trends: The Urine Drug Testing Crackdown and Three Ways to Avoid It
False billing of urine drug tests (UDTs) continues to be a focus for enforcement agencies in 2023, here’s how to avoid compliance issues.
OIG Semi-Annual Report Calls Out Drug, Genetic, and COVID-19 Testing Fraud
These three lab testing areas were the main sources of fraud and abuse revealed in the OIG’s latest Semi-Annual Report to Congress.
Special Report: The Current State of Genetic Testing Fraud Enforcement
Current genetic testing enforcement trends and what you can do to minimize the liability risks of your lab.
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
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.
High Billing by Labs Continues to Be Trigger for Audits
As we move further into 2023, COVID-19, add-on, and genetic tests will likely remain targets for federal regulators.
Why Mobile Phlebotomy Companies and Labs Should Be on Alert
Recent fraud case involving phlebotomy company shows why labs need to pay special attention to Medicare specimen collection and travel allowance rules.
Lab Sales & Marketing Compliance: The Current State of EKRA
Sales and marketing operations liability risks and the measures labs should and shouldn’t take to manage those risks.
Lab Owner Convicted for $463 Million Genetic Testing Fraud
Case is a recent example of the trend toward Medicare schemes involving telehealth, cancer genetic testing, and kickbacks.
FY 2022 OIG Enforcement Rebounds—but Recovery Dollars Don’t Show It
The agency’s latest report to Congress shows that while enforcement activity is returning to pre-pandemic levels, recoveries are still down.
SCOTUS Won’t Weigh in on How Whistleblowers Make Valid FCA Claims
The court recently denied the petition to hear a case that would have helped offer clarity on what evidence whistleblowers need to file qui tam lawsuits under the FCA.
