EMERGING TESTS

At-Home, Smartphone-Based Urine Testing Now a Clinical Reality

In what has been called the "era of the medical selfie," at-home, smartphone-based urine testing is now a reality. In a short timeframe, the U.S. Food and Drug Administration (FDA) cleared … [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 PLANS

OIG Monthly Work Plan Review: November 2018

This month, there were six new Work Plan items, two of which have implications for at least some labs. 1. CDC's Oversight of the President's Emergency Plan for AIDS Relief Funds Issue: Through the … [Read more...]

TESTING STRATEGY

FDA Enabling New Point-of-Care Tests for Ebola Outbreak, Flu Season

Several recent U.S. Food and Drug Administration (FDA) actions are bringing point-of-care (POC) infectious disease tests closer to patient care. These recent regulatory wins are enabling more rapid … [Read more...]

CMS

Medicare Appeals: CMS Tries to Speed the Process & Unjam the Backlog

On Oct. 2, CMS proposed revisions to rules for appealing adverse Medicare claim determinations (Proposed Rules).  The goal is to speed the process that currently takes three to four years and loosen … [Read more...]


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