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
- Updates on changes to regulations
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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
OIG Releases 2016 Work Plan, Again Targeting Laboratory Billing
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Re-evaluate and Update Your Compliance Plans
From - G2 Compliance Advisor
The Department of Justice (DOJ) and the U.S. Department of Health and Human Services' Office of Inspector General (OIG) have been very active in fraud prevention and enforcement, recovering $3.3 billion in taxpayer dollars in…
HCCA Releases Compliance Officer/Staff Compensation Data
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Point-of-Care Tests Likely to Become Bigger Factor in Lab Business Moving Forward
From - Laboratory Industry Report
For decades, the mechanics of laboratory testing have been at a physical remove from the bulk of health care delivery. A blood draw or tissue sample is performed on a patient at one site and…
HHS’ Top Ten Management Problems Include Labs
By Kelly A. Briganti, Editorial Director, G2 Intelligence The OIG's FY 2015 Top Management and Performance Challenges target clinical laboratories among other providers as a necessary focus of efforts to fight fraud, abuse and waste in Medicare. Specifically, the...
HHS’ Top Ten Management Problems Include Labs
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FCC Names Spectrum Coordinator, Paving Way for Remote Patient Monitoring
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FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
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Special Focus: The Rise of Liquid Biopsy Testing
From - Diagnostic Testing & Emerging Technologies
Early in the year DTET spoke to experts that predicted 2015 would be the year that liquid biopsy technology penetrates the clinical oncology market. These predictions did not disappoint. A near continuous stream of publications, conference presentations, and…
Avellino Expands Gene Testing for LASIK Prep Test
By Ron Shinkman, Editor, Laboratory Industry Report California-based Avellino Labs has expanded its molecular testing menu for patients who are considering lasik or other elective surgeries that will alter the structure of their eyes. Elective laser eye surgery,...