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
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
HHS’ Top Ten Management Problems Include Labs
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ACMG Issues Position Statement on Direct-to- Consumer Tests
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Six Protein Markers May ID Mood Disorders
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Congress Lobbies CMS on PAMA Regulations
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Trust for America’s Health Report:
Public Health and Clinical Laboratories Need to be Ready for New Disease Threats
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Insurers’ Genetic Counseling Requirements Impede Testing, ACOG Says
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FDA Looks Back at Successes and Details Plans for 2016, Including LDTs
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Pathway Genomics Denies Wrongdoing, Settles False Claims Allegations for $4 Million
From - G2 Compliance Advisor
As the year came to a close, the Federal Bureau of Investigation and the U.S. Attorney's Office announced December 30, 2015, a $4 million settlement with Pathway Genomics. The San Diego-based laboratory denied wrongdoing but agreed to pay that sum to resolve…
NeoGenomics Completes Clarient Acquisition
From - Laboratory Industry Report
Florida-based NeoGenomics has completed its acquisition of the Clarient Diagnostics unit from GE Healthcare. Clarient provides cancer diagnostics to hospitals, physicians, and drug companies…
Simple Patient Info Sheet Not Enough to Dissuade Low-Value Screening
From - Diagnostic Testing & Emerging Technologies
Simple, brief, information sheets are unlikely to change patients' intentions to participate in low-value screenings, according to a study published online…