FDA

FDA Hikes Premarket Application User Fees by 2.5 Percent

Applying for FDA premarket review of medical devices will be more expensive next year. On August 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]

Reimbursement

Biden Pulls Plug on Automatic Medicare Coverage for MCIT “Breakthrough” Devices

In a reminder of why politics and presidential elections matter so much, the Biden administration announced that it’s scrapping a Trump regulation that would have automatically provided initial … [Read more...]

EMPLOYMENT LAW UPDATE

White House requires all private-sector employers with 100 or more employees to mandate vaccination or a weekly negative COVID-19 test

By Mike O'Brien President Biden spoke from the White House Sept. 9 to announce his new Path Out of the Pandemic Plan. Among other things, President Biden has instructed the Occupational Safety and … [Read more...]

Compliance Perspectives

The 5 Things to Do When Implementing a Vaccine Passport Policy at Your Lab

Like many labs and other health providers, you might have been undecided about whether to mandate that your employees get the COVID-19 vaccine. However, now that the FDA has fully approved a … [Read more...]

Billing and Coding

Medicare to Reimburse 6 New CLIA-Waived Tests, Starting Oct. 1

The FDA recently approved a half a dozen assays as CLIA-waived tests that Medicare will reimburse when properly billed and coded by CLIA-certified labs. On Aug. 6, CMS sent out coding instructions to … [Read more...]

DX Deals

Amazon Already Making a Mark on Direct-to-Consumer COVID-19 Test Market

Will Amazon transform diagnostic lab testing the way it did the retail industry? Probably not. But the tech giant with the proven capacity to reach into the home and change the shopping patterns of … [Read more...]

Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Self-Disclosing Saves Kentucky Lab Over $1 Million in False Claims Settlement Case: A Kentucky-based lab that made heroic efforts to step up its COVID-19 testing early in the pandemic has agreed to … [Read more...]

Testing Trends

FDA Regulation of COVID-19 Testing Enters a New Phase

The public health emergency (PHE) is still in effect but the honeymoon has ended. The leniency that the U.S. Food and Drug Administration (FDA) has displayed toward COVID-19 tests and test makers … [Read more...]

DATA SECURITY

Health Care Data Breaches Hit a New High in First Half of 2021

While health care data breaches have become an all-too-common occurrence, the problem seems to be getting worse. According to the HHS’ Office for Civil Rights (OCR), there have already been 360 … [Read more...]

DX Deals

Amazon Already Making a Mark on Direct-to-Consumer COVID-19 Test Market

Will Amazon transform diagnostic lab testing the way it did the retail industry? Probably not. But the tech giant with the proven capacity to reach into the home and change the shopping patterns of … [Read more...]


(-00000g2)