HIPAA

Breach Notification Violation Ends in $475,000 Settlement

Patient health information breaches—whether from hacking, glitches or just plain old carelessness—remain an all too common occurrence in labs and other health care institutions. Three years ago, a new … [Read more...]

COMPLIANCE

OIG Updates Threshold for Nominal Value Gifts

Just as the civil monetary penalties have gotten an update to adjust for inflation (see "Civil Monetary Penalties Rules Updated" Lab & Pathology Insider, Jan. 3, 2017), so too have the thresholds … [Read more...]

FALSE CLAIMS

DOJ Surveys False Claims Victories for 2016

As we closed out the calendar year, the U.S. Department of Justice (DOJ) reflected on its successes for the fiscal year 2016 (FY 2016) which ended Sept. 30, 2016. Principal Deputy Assistant Attorney … [Read more...]

COMPLIANCE

Labs Beware: New Rules Impose Harsher Civil Monetary Penalties

It may be facing repeal but the Affordable Care Act (ACA) is not going down without a squawk. On Dec. 7, the Office of Inspector General (OIG) accomplished a key piece of ACA business by adopting … [Read more...]

COMPLIANCE

New OIG Advisory Opinion Repeats Warning that Free Labeling Services Can Be Kickbacks

The government's longstanding aversion to labs providing free items or services to referral sources remains unaffected by changes in reimbursement methods. A laboratory sought an advisory opinion from … [Read more...]

ENFORCEMENT

2017 OIG Work Plan Holds Few Surprises for Labs

There are few surprises in the Health and Human Services Office of Inspector General's 2017 Work Plan. The OIG's annual Work Plan provides a summary of new and continuing reviews that the agency is … [Read more...]

ENFORCEMENT

OIG Releases 2017 Work Plan

There are few surprises in the Health and Human Services Office of Inspector General's 2017 Work Plan. The OIG's annual Work Plan provides a summary of new and continuing reviews that the agency is … [Read more...]

BRIBES

FCPA Self-Disclosure Pilot Program Continues Focus on Individual Accountability

In the modern age of global commerce, the Foreign Corrupt Practices Act (FCPA) has increasing relevance for laboratories and the diagnostics industry. Alere, a point-of-care diagnostic test maker, … [Read more...]

PATIENT SAFETY

List of Top 10 Patient Safety Concerns Implicates Lab-Related Issues

Four of the top 10 patient safety concerns, compiled from reports of more than 1.2 million safety events, literature review and expert opinion, have relevance for laboratories and diagnostics. ECRI … [Read more...]

PATIENT SAFETY

Top 10 Patient Safety Concerns Include Lab Related Issues

By Kelly A. Briganti, Editorial Director, G2 Intelligence Four of the top 10 patient safety concerns, compiled from reports of more than 1.2 million safety events, literature review and expert … [Read more...]


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