June 2024

ACLA Files Federal Court Challenge to FDA’s Final LDT Rule

BATTLE LINES ARE NOW DRAWN ON WHAT IS PROBABLY THE BIGGEST CONFRONTATION between the clinical laboratory industry and federal regulators in the past 50 years. On May 29, the American Clinical Laboratory Association (ACLA) with co-plaintiff HealthTrackRx filed a major lawsuit against the federal Department of Health and Human Services (HHS) and Food and Drug […]

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LDT Rule Is Now a Fact! What Will Be Consequences?

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) issued by the federal Food and Drug Administration (FDA) is an accomplished fact. In taking this action, the FDA has created a regulatory scheme that is widely viewed as disruptive and counter-productive by pathologists and clinical lab executives involved in performing LDTs in support

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ACLA Files Court Challenge to FDA’s Final LDT Rule

Laboratory Compliance / Robert Michel

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 “genie” in federal court, with the goal of

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ACLA President Van Meter Discusses LDT Lawsuit

Laboratory Compliance / Robert Michel

CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In this exclusive interview, ACLA President Susan Van Meter provides insight

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Attorneys Assess Impact of FDA’s Final LDT Rule

Laboratory Compliance / Robert Michel

CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and what they hear from their clinical laboratory clients. THROUGHOUT THE CLINICAL LABORATORY

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Several Times, Feds Tried to ‘Redirect’ Lab Activities

Laboratory Compliance / Robert Michel

CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look back at other important federal laws and regulations that triggered

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What if Congress Chooses to Pass an LDT-Specific Law?

Laboratory Compliance / Robert Michel

CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed tests (LDTs). Influential advocates on both sides of this issue have lobbied lawmakers on this issue for a decade. Given the stakes involved in the specifics of how laboratory developed tests are regulated, it is reasonable to assume that representatives and senators

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How Private Health Insurers May Respond to FDA LDT Regulation

Managed Care Contracts / Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. HOW MIGHT PRIVATE HEATLH

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June 10, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Once a high-flier lab test manufacturer with a market valuation of $2 billion, Cue Health of San Diego filed for Chapter 7 bankruptcy on May 28. Analysts now say the company is valued at about $15 million. Founded in 2010, Cue Health was developing a test system that consumers could use at home. Its components

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