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
December 14, 2018
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
December 14, 2018
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
December 10, 2018
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
December 3, 2018
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
November 16, 2018
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
November 16, 2018
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
November 16, 2018
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
November 12, 2018
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
October 25, 2018
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...]
