In this issue:

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In this issue:

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In this issue:

Will clinical labs be excluded from the new proposed safe harbors under the Stark Act and the AKS? THE DARK REPORT analyzes the problem and also the warning that lies within CMS’ plans for revisions to the anti-fraud laws. Also in this issue are key health system strategies and lab objectives from inside the highly successful switch to value-based medicine at one hospital lab, which was once considered a candidate for sale.

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THE MOST IMPORTANT STORY OF THE YEAR is actually 10 stories. THE DARK REPORT delivers a must-read overview of a turbulent 2019 that delivered mostly bad news, but also some opportunities for those with nimble management feet. Also, in Part 2 of our report on lawsuits filed in federal court against the two national labs, an insider-turned-whistleblower makes revealing allegations about the internal policies governing charging high prices to the uninsured patient.

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UNDERREPORTED BUT CRITICAL TRENDS dominate this issue of THE DARK REPORT. In one, the evidence shows that ICD-10 codes’ richer data are now giving payers brand new opportunities to reject lab payment claims or even try to claw back payments already made. Also, lawsuits alleging that the Blood Brothers are overcharging uninsured patients might actually be an opportunity for labs to be more competitive with the big national labs.

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THE DARK REPORT DETAILS THE NEW CMS RULE targeting Medicare fraudsters that could entrap clinical labs and pathology groups. At the same time, attorneys outline ways for labs to navigate this new minefield and avoid problems. Also, an expert details six different ways that labs can use their valuable data — without selling it — to improve patient care and lower healthcare costs, with new revenue streams as a bonus.

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ALL LABORATORIANS must take heed of the disruptive new trends in the healthcare industry, which will affect the way patients, doctors, labs, payers and others interact with each other. Also, THE DARK REPORT explains how a genetic testing fraud, recently the target of federal prosecutors, was executed by the alleged perpetrators.

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A MAJOR HEALTH NETWORK is addressing the opioid crisis: Community Health Network of Indianapolis recognized that clinical lab toxicology tests are one of the few sources of objective data about patient compliance, and is using that data in its new Chronic Opioid Therapy program. This first-time intelligence briefing on such a program also includes insights about lessons learned and discusses how offering additional analytical reports and services add value to the health network’s COT patient management program.

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SOME PATHOLOGISTS AND LAB EXECUTIVES find the FDA’s latest actions regarding pharmacogenetic testing confusing, unclear and beyond the FDA’s authority. Other observers note that the FDA does indeed have a legitimate concern. THE DARK REPORT examines both sides of this controversy. Also reported is the opinion of respected pathology consultants that the result of deep fee cuts by Anthem to some anatomic pathology services will harm patients.

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THE DARK REPORT TAKES A DEEP DIVE into the alleged lab fraud case against True Health Diagnostics, which has seen its CMS reimbursement completely cut off, leading the company to file for bankruptcy. The details will help laboratory management understand how a single case of alleged lab fraud affects all labs. Also, TDR is the only lab news source to report on how the leaders of some physician specialties are criticizing Anthem for cutting anatomic pathology professional fees by as much as 70% in states across the nation.

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