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ACLA Files Court Challenge to FDA’s Final LDT Rule

CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.” ACLA and HealthTrackRx are challenging the FDA’s …

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Significant Developments Are Shaping Lab Market

CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different spea…

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FDA Issues Proposed Rule to Further Regulate LDTs

CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…

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Draft Rule Standardizes Electronic Signatures

CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…

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Clinical Laboratories Face 20% Increase in CLIA Fees

CHANGES HAVE BEEN PROPOSED to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that would raise fees by 20% for clinical laboratories and amend certain testing personnel qualifications.  The American Hospital Association (AHA) has obj…

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Federal Rule to Revise Out-of-Network Billing

CEO SUMMARY: Remaining out of network with health insurance companies may boost revenue for providers, including anatomic pathologists and emergency room physicians. But the good times may soon end. Last month four federal agencies issued rules that implement new requirements under …

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Comment Period Closing on Federal Surprise Billing Rule

PATHOLOGY GROUPS AND CLINICAL LABS HAD UNTIL SEPTEMBER 7 to comment on an interim final rule that provides federal protections against surprise billing and limits out-of-network (OON) cost sharing under many of the circumstances in which surprise bills arise most frequently….

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