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
U.S. Supreme Court Says Failure to Disclose Noncompliance Can Lead to False Claims Liability
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Palmetto Lays Out Analytical Validity Requirements for Liquid Biopsy
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Senior Medicare Patrol Projects Show Low ROI in Fighting Fraud and Abuse
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Largest Takedown in Strike Force History Alleges $900 Million in False Medicare Billing
From - G2 Compliance Advisor
Nearly a year to the day after another nationwide Strike Force takedown, the Department of Justice announced last week what it says is a…
Genetic Test Registry Finds Growth of Oncology, NGS-Based Tests
From - Diagnostic Testing & Emerging Technologies
The number of cancer gene tests has grown tremendously in the past two years, particularly in the field of oncology where the number of tests grew by…
U.S. Supreme Court Recognizes FCA Liability for Implied False Certification
From - National Intelligence Report
While the long awaited release of the PAMA rule has received a lot of attention, a significant False Claims Act (FCA) decision by the U.S. Supreme Court was also…
Kailos, Huntsman Institute Receive NIH Grant to Develop Cancer Recurrence Test
From - Laboratory Industry Report
The Alabama-based Kailos Genetics and the Huntsman Cancer Institute at the University of Utah have received a $2.4 million grant from the…
Final PAMA Rule Released, Implementation Delayed to 2018
From - National Intelligence Report
After much lobbying, debate and delay, the Centers for Medicare & Medicaid Services (CMS) final rule implementing the Protecting Access to Medicare Act (PAMA) changes to the Clinical Laboratory Fee Schedule (CLFS) was released…
Data Analytics Fuels Billions of Dollars in Fraud Recoveries Says OIG, CMS
From - G2 Compliance Advisor
A common message emerging from the government enforcement agencies is that data analytics have been critical to fraud and…
USPSTF Updates Colorectal Cancer Screening Guidelines to Include Molecular Test
From - Diagnostic Testing & Emerging Technologies
The U.S. Preventive Services Task Force (USPSTF) added molecular colorectal cancer (CRC) screening to its newly updated guidelines, but stopped short of…
