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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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
Quest Pays $88.7K to Settle Specimen Collection Fee Kickback Charges Against Its Subsidiary
Alabama Doctors, Cardio Practice, Settle Genetic Testing Kickback Claims for $1.1 Million
New Jersey Lab Hit with $144.6K Settlement Tab for Improper Billing of Nerve Conduction Studies
Compliance Perspectives: Avoid HIPAA Violations When Denying Patient Requests to Amend PHI
On Sept. 9, 2019, the HHS Office for Civil Rights (OCR), the agency that enforces HIPAA rules, announced that it had done something it has never done before: settle an enforcement action for not complying with HIPAA provisions ensuring individuals access to their...
FDA Watch: Expanded Label Clearance Opens Cologuard to a Younger Market
September was an eventful month for one of the hottest products on the consumer genetic test market, the Cologuard multi-target stool DNA test (mtSDNA) for colorectal cancer screening produced by Exact Sciences. The month started badly with the release of a CMS-sponsored research report finding Cologuard “less effective and considerably more costly” than alternatives. Although Exact Sciences quickly criticized the report and its analytical methodology, its stock took a beating.
