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
Enforcement Trends: Opioid Crackdown Zeroes in on Urine Drug Testing-Today the Doctors, Tomorrow the Labs
From - G2 Compliance Advisor
A 67-year-old Michigan M.D. is the most recent doctor taken down in what has become a crucial part of the federal government's opioid drug crusade…
Enforcement Trends: The OIG’s Recent Safe Harbor Changes
From - National Intelligence Report
On February 26, the OIG will wrap up public comments on changes to the federal Anti-Kickback Statute (AKS) current safe harbor rules…
Study Shows Progress Towards a Blood-Based, Multi-Cancer Screen
From - Diagnostic Testing & Emerging Technologies
A blood-based screening test capable of detecting multiple forms of early cancer just took one step closer to becoming a reality. A study published…
FDA Watch: Off-Label Marketing Rule Put Back on Ice & Extra Comment Time for CLIA Waiver Proposals
From - Laboratory Industry Report
For the second time in less than a year, the FDA indefinitely delayed a controversial rule expanding its authority to regulate off-label marketing…
Case of Month: Using Window Envelope to Mail HIV Info Costs Aetna $17+ Million
From - National Intelligence Report
You talk about a mailroom mess-up! A shockingly bad choice in envelopes has just cost one of the country's largest health insurers over…
Penicillin Skin Testing Can Delabel Misidentified Allergic Patients
From - Diagnostic Testing & Emerging Technologies
In an era of growing concerns over antibiotic stewardship, there is renewed interest in delabeling misidentified penicillin allergies as part of quality improvement efforts…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: Texas-based United Allergy Services (UAS) is suing Quest Diagnostics for conspiring with…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Here's a rundown of the key diagnostic product launches from mid- December through late January…
Strategic Alliances, Partnerships & Collaborations Analysis – February 2018
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Enforcement Trends: Whistleblowers Get in on the EHR “Meaningful Use” Action
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