Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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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
Legalization of Marijuana Raises Need for Testing to Detect Impaired Drivers
From - Diagnostic Testing & Emerging Technologies
With the movement to legalize marijuana use for medical and/or recreational purposes gaining traction, states are calling for…
Challenge: Build a Better Medical Bill
From - National Intelligence Report
The U.S. Department of Health and Human Services (HHS), in collaboration with AARP, is challenging health care organizations to design a…
Genomic Health Test Linked to High Prediction of Recurring Distant Breast Cancer
From - Laboratory Industry Report
A new study in the New England Journal of Medicine has given credence to a molecular assay by California-based Genomic Health as a…
CMS Releases Data on Medicare Payments to Providers, Including Clinical Labs
From - G2 Compliance Advisor
For a third year in a row, the Centers for Medicare & Medicaid Services (CMS) has released updated data regarding Medicare payments with its Physician and…
FDA Releases Draft Guidance for NGS-Based Tests for Infectious Disease Diagnosis
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Industry Challenged to Create More Patient-Friendly Medical Billing System
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Online Tool Helps ID Rare Pathogens
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Datapalooza Highlights the Value of Data
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Third Annual Release of Medicare Payment Data Furthers Transparency Regarding Lab Payments
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US Patent Office Issues Guidance Targeting Diagnostic-Related Patent Claims
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