Three months into the pandemic, HHS has decided that it would be a good idea for labs that perform COVID-19 testing to report not only test results but other real-time data that labs generally don’t … [Read more...]
New Laws
HHS Requires Labs to Report Extensive & Unprecedented COVID-19 Testing Data by August 1
June 17, 2020
The Coronavirus Crisis
Test-Now, Regulate-Later Strategy Generates Robust Dx Test Pipeline in Record Time
April 17, 2020
Historically, the lag between Public Health Emergency (PHE) declaration and FDA approval of a lab test to diagnose the pathogen has been a minimum of eight weeks. Eight weeks into the coronavirus PHE, … [Read more...]
LDTs
Laboratory Developed Tests: The VALID Act is Back
March 18, 2020
With all the attention commanded by the coronavirus crisis, a potentially huge development affecting the future of the lab industry has flown under the radar. What’s at stake is the issue that has … [Read more...]
CMS Increases 2020 Maximum Civil Monetary Penalties
February 27, 2020
Every year, HHS adjusts for inflation the maximum civil monetary penalty (CMP) amounts that a lab or other provider can be fined. In 2020, CMP maximums will increase by 2.522%. The new higher CMP … [Read more...]
ENFORCEMENT
Enforcement Trends: False Claims Act Recoveries Increase as Labs Remain in Firing Line
January 24, 2020
The dollars paid by healthcare providers in federal False Claims Act settlements and judgments increased for the second year in row in 2019. After a surprising decline in 2017, total recoveries … [Read more...]
ENFORCEMENT
Enforcement Trends: The Top 5 Lab False Claims Act Settlements of 2019
January 24, 2020
Labs were on the paying end of at least eight million-dollar False Claims Act (FCA) settlements or judgments in the 2019 fiscal year. Here’s a review of the top 5 reported FCA recoveries against a lab … [Read more...]
News
CMS Delays Controversial Hospital Price Transparency Rules
November 14, 2019
CMS has decided to delay its controversial proposal to require hospitals to post their standard prices based on their negotiated contracts with insurers. But while the delay represents a temporary … [Read more...]
CMS
Reimbursement: CMS Increases 2020 AIC Medicare Appeal Thresholds
November 14, 2019
Appealing Medicare denials and other unfavorable decisions will be just a tad more difficult in 2020. Here’s why: Medicare AIC Thresholds Medicare rules (specifically, Section 1869(b)(1)(E) of … [Read more...]
Quest Shells Out $195K to Settle Massive HIV Data Breach Class Action
November 14, 2019
Government fines, public embarrassment, loss of provider and patient trust. As if these consequences weren’t scary enough, massive PHI breaches can expose your lab to a new kind of risk: class action … [Read more...]
Global News: EU Delays Launch of Eudamed Database
November 14, 2019
The European Commission (EC) is delaying the launch of the European database on Medical devices (aka Eudamed) until May 2022. Originally, manufacturers were supposed to be compliant by May 2020 with … [Read more...]
