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Diagnostic Testing and Emerging Technologies

LAB COMPLIANCE ADVISOR

LABORATORY INDUSTRY REPORT

NATIONAL LAB REPORTER

FDA to Hold Off on Enforcing New Medical Device Cybersecurity Requirements

FDA to Hold Off on Enforcing New Medical Device Cybersecurity Requirements

by Glenn S. Demby | Apr 26, 2023 | News

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

Lab Owner Charged in Latest COVID-19 Fraud Crackdown

by Rachel Muenz | Apr 26, 2023 | News

In the latest major COVID-19-related enforcement action, 18 individuals were charged in various schemes worth more than $490 million.

Compliance Alert: Start Using New ABN Form on June 30

Compliance Alert: Start Using New ABN Form on June 30

by Glenn S. Demby | Apr 24, 2023 | News

Labs must use the new Advance Beneficiary Notice of Noncoverage (ABN) form starting on June 30, 2023, when the old version expires.

Federal Court Tosses Consumer Fraud Lawsuit Against Labcorp

Federal Court Tosses Consumer Fraud Lawsuit Against Labcorp

by Glenn S. Demby | Feb 22, 2023 | News

Not disclosing list prices of uncovered lab tests on ABN is not consumer fraud, court says.

Weekly Enforcement Report: Medical Equipment & Kickbacks

Weekly Enforcement Report: Medical Equipment & Kickbacks

by Rachel Muenz | Jan 25, 2023 | News

While labs were absent from recent enforcement actions, last week saw kickback schemes involving DME companies and a medical device company.

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