Public Health

U.S. Needs 200 Million COVID-19 Screening Tests Per Month to Reopen Safely, Says New Report

How many COVID-19 screening tests per month will it take for the U.S. to reopen safely? One new report estimates the number as around 200 million, which is far below the 25 million tests currently … [Read more...]

COVID-19

Strapped by COVID-19 Testing Supply Shortages, Labs Call on White House for Help

Reagent shortages and supply chain bottlenecks have stymied COVID-19 testing from the very beginning of the crisis. As those problems remain and tests provided slips further behind demand, a handful … [Read more...]

New Laws

HHS Requires Labs to Report Extensive & Unprecedented COVID-19 Testing Data by August 1

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...]

The Coronavirus Crisis

Test-Now, Regulate-Later Strategy Generates Robust Dx Test Pipeline in Record Time

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

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...]


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