The Dark Report Archives

UK’s Genomics PLC and MassMutual Offer Free Genetic Testing to Members

CONSUMER-DRIVEN HEALTHCARE PAIRED WITH A FOCUS ON PREVENTATIVE MEDICINE has given birth to powerful partnerships that are using genetic testing to encourage patients to make informed decisions for their health and wellbeing. One such example is Genomics PLC (Genomics), a healthcare company out of Oxford, England, which partnered with Massachusetts Mutual Life Insurance Company (MassMutual) […]

To access this post, you must purchase The Dark Report.

UK’s Genomics PLC and MassMutual Offer Free Genetic Testing to Members Read More »

Behind-the-Scenes Audits Often Hide Cause of Test Claim Denials

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 man age their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. PRIVATE PAYER AUDITS

To access this post, you must purchase The Dark Report.

Behind-the-Scenes Audits Often Hide Cause of Test Claim Denials Read More »

Global IVD Companies Report First Quarter 2024 Earnings

In Vitro Diagnostics / Robert Michel

IN THEIR INITIAL FINANCIAL REPORTING FOR 2024, in vitro diagnostics (IVD) company leaders shared priorities and progress in the first quarter (Ql) while also acknowledging heightened competition in diagnostics. And, for some of the IVD manufacturers, a need for new leaders and perspective is being addressed. Here is a summary of recent financials, key accomplishments,

To access this post, you must purchase The Dark Report.

Global IVD Companies Report First Quarter 2024 Earnings Read More »

July 1, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Last week, it was announced that Quest Diagnostics “would acquire select laboratory assets from 12-hospital Allina Health” the Minneapolis-based health system. Quest stated, “Under the terms of the definitive agreement, Quest will offer its laboratory services to Allina Health clinic physicians and outreach provider clients across Minnesota and western Wisconsin:” No price was announced and

To access this post, you must purchase The Dark Report.

July 1, 2024, Intelligence: Late-Breaking Lab News Read More »

Is It Time for Clinical Labs to Embrace Consumers?

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

HEALTHCARE IN THIS COUNTRY HAS A WELL-DESERVED REPUTATION for being slow to incorporate new clinical knowledge, technologies, and management models into daily practice. Adoption of these innovations by hospitals, physicians, and clinical laboratories often lags behind other industries by several years. Seen in this context, today’s “new consumer” is one of those powerful developments that

To access this post, you must purchase The Dark Report.

Is It Time for Clinical Labs to Embrace Consumers? Read More »

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

To access this post, you must purchase The Dark Report.

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

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

To access this post, you must purchase The Dark Report.

ACLA Files Court Challenge to FDA’s Final LDT Rule Read More »

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

To access this post, you must purchase The Dark Report.

ACLA President Van Meter Discusses LDT Lawsuit Read More »

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

To access this post, you must purchase The Dark Report.

Attorneys Assess Impact of FDA’s Final LDT Rule Read More »

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

To access this post, you must purchase The Dark Report.

Several Times, Feds Tried to ‘Redirect’ Lab Activities Read More »