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...]

Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test … [Read more...]

Labs In Court

NIPT Lab Company Pays $49 Million to Settle False Billing and Kickback Charges

Case: A month after going public, Progenity agreed to shell out $49 million to settle claims of overbilling and paying physicians kickbacks to order its noninvasive prenatal tests (NIPT). The case, … [Read more...]

FDA Watch

Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs

The COVID-19 pandemic has exposed how the FDA’s makeshift premarket control over laboratory developed tests (LDTs) stifles innovation and keeps desperately needed new tests from reaching the market. … [Read more...]

DX Earnings Report

Q2 Revenues Slide but By Less than Wall Street Expected

As expected, the COVID-19 pandemic took a tremendous bite out of lab company earnings in the second quarter. However, the losses were largely below expectations, significantly below in many cases. And … [Read more...]

False Claims Act

Federal Appeals Court Tosses Cold Water on DOJ’s Crackdown on Weak Whistleblower Suits

It’s fair to say that when it comes to False Claims Act (FCA) whistleblower qui tam lawsuits, the current U.S. Department of Justice (DOJ) is less enthusiastic than its predecessor. In fact, the DOJ … [Read more...]

FDA Watch

Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks

Shortages of the nasopharyngeal swabs used to collect respiratory samples for reverse transcription polymerase chain reaction (RT-PCR) tests has impeded the efforts of laboratories to meet the … [Read more...]

DATA

UK Antibodies Prevalence Study Suggests that Minorities Contract COVID-19 at Disproportionately Higher Rates

Many have suggested that minority populations have suffered adverse effects from COVID-19 disproportionate numbers. An August study from the United Kingdom provides powerful evidence to support this … [Read more...]

Medicare Reimbursement

The 4 Things Labs Need to Know about CMS’ Newly Proposed 2021 OPPS Rule 

On Aug. 4, CMS posted the proposed Outpatient Prospective Payment System (OPPS) Rule for 2021.  In case you don’t feel like reading all 785 pages of the Rule, here’s a high level summary of the four … [Read more...]

New Laws

January 1, 2021 Is D-Day for Hospital Pricing Transparency 

It appears to be full speed ahead for hospital price transparency. The controversial effort to make hospitals divulge information about their healthcare pricing, including lab procedures, is very much … [Read more...]


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