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
Genetic Profiling: Study Casts Doubt on Cost-Effectiveness of Leading Breast Cancer Recurrence Assay
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FDA Watch: Extra Time for Comments on CLIA IVD Waiver Proposals
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Influenza Testing: Study Finds Older Patients Are Under-Tested and Under-Diagnosed
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Anti-Kickback Statute: OIG Eyes Changes to Safe Harbor Rules
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Venture Capital Investment in Diagnostic Companies Strong in 2017
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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…
