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
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
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Survey Reveals Cybersecurity and Social Media as Top Compliance Concerns
Cybersecurity is a top compliance concern according to a survey of compliance professionals conducted by Health Care Compliance Association (HCCA) and the Society of Corporate Compliance and Ethics (SCCE). In January 2016, HCCA and SCCE surveyed 900 individuals,...
AACC Adds to List of Alternative LDT Oversight Proposals
Another industry trade group has chimed in on the issue of the U.S. Food and Drug Administration (FDA) regarding its intent to regulate laboratory developed tests (LDTs). The American Association of Clinical Chemistry (AACC) issued a position paper urging the FDA...
Federal Agencies Prepare to Battle Zika Virus in the U.S.
As spring arrives and the threat of Zika virus grows in the U.S., the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are taking action to address the virus threat. April 1, 2016, the Centers for Disease Control and...
News at a Glance
HHS Reports Medicare Spending Declined. After announcing that the goal of linking 30 percent of Medicare payments to quality was reached months earlier than anticipated, the U.S. Department of Health and Human Services (HHS) reported that Medicare spending between...