Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Researchers Develop First Multiplex Test for Tick-Borne Disease Detection
From - Diagnostic Testing & Emerging Technologies
Researchers have developed the first multiplex array for diagnosis of tickborne diseases, according to a study published online…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: A physician coding supervisor for a North Carolina health system that used billing software from Epic filed a qui tam lawsuit against the firm claiming that the…
By the Numbers: Spike in M.D. Practice Acquisitions Drives Up Costs of Hospital Care
From - Laboratory Industry Report
Hospitals are gobbling up M.D. practices at a record rate. In addition to endangering the independent physician practice, this trend is driving up the costs of…
Diagnostic danger in the lab: Time to reform how we process orders
Recent report examining 10,000 claims to understand the key drivers of medical malpractice suits found 52 percent involved lab-related errors.
New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse
From - National Intelligence Report
Sneaky may be too strong a word. But what is fair to say is that the new hikes in federal health care fraud violation penalties have flown totally under the radar despite…
Testing Guidelines at a Glance
From - Diagnostic Testing & Emerging Technologies
New Recommendations Simplify Testing for Chronic Kidney Disease
In late February, The National Kidney Foundation, the American Society for Clinical Pathology, and leading laboratories and…