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...]
PAMA
PAMA Report: ACLA Tries for Decisive Blow in Federal Court Case
November 14, 2019
Now that its lawsuit challenging the PAMA pricing scheme is back in the lower federal court, the American Clinical Laboratory Association (ACLA) went back on the offensive by moving for summary … [Read more...]
FDA
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
September 16, 2019
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict patients' responses to medications. It began in 2018, when the FDA warned consumers and … [Read more...]
FDA
Inside Washington: What’s Going on with Regulation of LDTs?
September 9, 2019
Although things appear to be quiet, progress is actually being made in the quest to create workable regulation of Laboratory Developed Tests (LDTs) developments. Here's a rundown of the latest … [Read more...]
PRECISION MEDICINE
Myriad Genetics Pays $9.1 Million to Settle Hereditary Cancer Test False Billing Claims
August 26, 2019
In March 2018, Myriad Genetics got a piece of mail no lab provider ever wants to see in its inbox: an OIG subpoena asking for billing records in connection with "an investigation into possible false … [Read more...]
CMS
Kickbacks: OIG Withdrawal of Old Safe Harbor Proposals Clears Way for Meaningful Reform
August 26, 2019
Like the rest of the health care industry, labs need more not fewer new and modern Anti-Kickback Statute (AKS) safe harbors. So, the OIG's decision to cancel new safe harbors in incubation seems like … [Read more...]
PAMA
Business Trends: More Hospitals Looking to Outsource Their Lab Testing
August 26, 2019
'Looking for new business opportunities? A new survey shows a substantial jump in the number of hospitals looking to outsource lab services. creating potential opportunity for labs. Although no … [Read more...]
