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
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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
Medicare Reimbursement: Federal Government Funding Extension Includes a Boatload of Medicare Changes
From - National Intelligence Report
The government shutdown fiasco is having an impact on Medicare spending and reimbursement. But the crucial details are being buried in the legislative paperwork…
CAP Files Amicus Brief in Support of ACLA Motion for Summary Judgement in PAMA Lawsuit
From - G2 Compliance Advisor
The College of American Pathologists (CAP) filed an amicus curiae brief in support of a motion by the American Clinical Laboratory Association (ACLA) for summary judgement to…
Industry Buzz: ACLA Goes for Kill in PAMA Lab Fees Challenge Case
From - Laboratory Industry Report
Attorneys for the American Clinical Laboratory Association asked the federal court for summary judgment in its lawsuit challenging…
FDA Approves First Objective Blood Test for Concussion Evaluation
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) recently approved the first blood test to evaluate concussions in adults…
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…