LDTs

Laboratory Developed Tests: The VALID Act is Back

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

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

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

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

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

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  

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

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

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

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...]


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