FOCUS ON

LDTs: FDA Announces New Approach to 510(k) Approvals

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]

Enforcement Trends: Opioid Crackdown Is Diverting Resources from Traditional OIG Enforcement Activities

The OIG won't admit it, but the opioid crackdown is diverting resources from traditional Medicare fraud and waste enforcement efforts. At least that's the most likely explanation for the dramatic … [Read more...]

PAMA

Medicare Reimbursement: ACLA Court Appeal Maintains 2-Front War for PAMA Relief

It's official. The ACLA is appealing the September federal court decision to dismiss its PAMA lawsuit (ACLA v. Azar). Here's a quick rundown of the three things you need to know. 1. The Legal … [Read more...]

INNOVATION

LDTs: FDA Approves First NGS Residual Cancer Detection Test

The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]

ENFORCEMENT

Feds Continue Roundup of Physicians on Receiving End of Millennium Labs Test Cups Freebie

The Millennium Laboratories free point of care test (POCT) cups scandal has been described as the biggest kickback scandal involving lab services in history. And its legacy has now entered a new … [Read more...]

COMPLIANCE GUIDANCE

Kickbacks: OIG Okays Incentivizing MDs to Order More Early Screening Tests

Proactive rather than reactive has become a mantra of the modern health care model. Early and periodic testing of patients is a critical element in this strategy. The problem is that not a lot of … [Read more...]

INNOVATION

Using Digital Technology and AI to Fight Cancer

It has the makings of a Hollywood movie. Three recent college grads start a medical testing software company that uses a digital pathology platform, meet with success, and then go on to utilize … [Read more...]

REIMBURSEMENT

MACRA: QPP Year 1 By the Numbers

On Nov. 8, CMS posted Merit-based Incentive Payment System (MIPS) performance results for 2017, the first year of the Quality Payment Program (QPP) which it will use to determine 2019 Medicare … [Read more...]

FALSE CLAIMS

Florida Doctor Jailed 5 Months for Lying to a Medicare Auditor

Lying to a Medicare auditor or otherwise obstructing a Medicare audit is a crime that can get you jailed. A 73-year-old endocrinologist specializing in diabetes management just learned that lesson the … [Read more...]

EXPOSED THERANOS FRAUD

Investigative Journalist Wins Kellison Award

John Carreyrou, the Pulitzer prize-winning journalist who exposed Theranos as a fraud, was presented with the Kellison & Company Distinguished Service Award at Lab Institute today. Pictured … [Read more...]


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