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
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
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Lab Industry Report: The Year in Diagnostics Mergers & Acquisitions
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PAMA-geddon: Lab Industry Goes to Court to Stop 2018 Medicare Fee Schedule
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LDTs: Top 10 New FDA Diagnostic Approvals of 2017
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CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look
From - National Intelligence Report
If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very…
FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway
From - Laboratory Industry Report
A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including…
Case of the Month: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests
From - G2 Compliance Advisor
While the feds have made urine drug testing of opioid drug patients their number one target for lab-related False Claims Act (FCA) charges this year, nuclear stress tests …
POC Susceptibility Testing No Aid for Antibiotic Prescribing with UTI
From - Diagnostic Testing & Emerging Technologies
Adding point-of-care (POC) susceptibility testing to POC culture does not improve appropriateness of antibiotic prescribing for patients with suspected…
Strategic Alliances, Partnerships & Collaborations Analysis – December 2018
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Strategic Alliances, Partnerships & Collaborations Analysis – July 2018
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