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
Kentucky Pain Clinic Pays $127K to Settle Specimen Validity Test Billing Claims
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Genomic Data Sharing: From Utopian Principle to Practical Reality
From - National Intelligence Report
As a principle, it's hard to take issue with Science's recommendation; but as the article itself notes, actually achieving genomic data sharing remains…
Brief Your CEO: Notify Your Lab Execs of Upcoming Stark Law Changes
From - Lab Compliance Advisor
One of the best ways to score points with your lab's executives is to warn them about legal changes before they happen and…
New Federal Taskforce to Speed Implementation of Emergency Use Diagnostics
From - Diagnostic Testing & Emerging Technologies
Three federal agencies announced the creation of a new taskforce to provide timely recommendations to laboratories for rapid implementation of…
Three key items to negotiate for successful payer contracts
By Steve Selbst bio
The purpose of this article is to help you, as a provider, to focus on three key items to look for in payer contracts that will help you to get profitable contracts in place…
Aetna to Pay California $935K for HIV Envelope Privacy Fiasco
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Compliance Perspectives: How to Spot & Avoid Kickback Risks under New EKRA Law
From - Lab Compliance Advisor
A new law passed to deal with the opioid epidemic has significant ramifications for labs including but not limited to those involved in drug addiction and…
Enforcement Trends: CMS Looks to Recover $66.3 Million in Improper Specimen Validity Test Payments
From - National Intelligence Report
The opioid crackdown has made urine drug testing an even greater priority for federal health fraud enforcers. One principle target is specimen validity testing…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
March was the most intense month of the year so far for new diagnostic products highlighted by 23andMe's launch of a new…
ASCO Endorses CAP’s Practice Guidelines for HPV Testing in Head, Neck Cancers
From - Diagnostic Testing & Emerging Technologies
The American Society of Clinical Oncology endorsed the American Pathologists' practice guidelines for human papillomavirus (HPV) testing in…
