The COVID-19 pandemic exposed the truth of something the lab industry has known and publicly stated repeatedly for over a decade: The FDA is ill-equipped to regulate Laboratory Developed Tests (LDTs) … [Read more...]
Reimbursement
Not Making Insurers Pay for Back-to-Work COVID-19 Testing May Leave Labs Holding the Bag
July 20, 2020
Who should pay for desperately needed COVID-19 testing? In the first stage of the public health crisis, the federal government’s answer was that insurers should pay the bills and not pass along the … [Read more...]
Two New Bills
New Federal Legislation Would Give Labs Grants to Expand COVID-19 Testing Capacity
June 17, 2020
We all hope the worst of the pandemic is over and that life can get back to something like normal. But even as America reopens, the disturbing truth remains that the virus is still out there and that … [Read more...]
COVID-19 Politics & Lab Testing
$3 Trillion HEROES Stimulus Bill Clears House Will Die in Senate
May 20, 2020
On May 15, the U.S. House of Representatives passed, by a vote of 208 to 199, a new $3 trillion COVID-19 stimulus bill that includes $75 billion to support diagnostic testing and contact tracing … [Read more...]
PAMA
COVID-19 Relief Bill Defers 2021 Medicare Part B Lab Test Price Cuts for One Year
April 14, 2020
The $2 trillion COVID-19 relief bill, CARES (Coronavirus Aid, Relief and Economic Security Act), provides for free coronavirus testing without adequately compensating the labs who perform the tests. … [Read more...]
Congress Moves One Step Closer to Passing “Surprise Billing” Legislation
Prospects for the passage of legislation banning “surprise billing” of patients before the presidential election advanced significantly on Feb. 12 with the powerful House Ways and Committee … [Read more...]
LEGISLATION
New Laws: Congress Tables Bill to Make Whole-Genome Sequencing Available to Medicaid Kids
August 26, 2019
In early August, Representatives Scott Peters (D-CA) and John Shimkus (R-IL) introduced in the US House of Representatives a bill to provide "certain undiagnosed children under the Medicaid program" … [Read more...]
REIMBURSEMENT
PAMAgeddon: Congress Tables Bill to Delay Next Round of Price Reporting for One Year
July 16, 2019
The PAMA data collection process has been a lightning rod for criticism from almost the moment CMS unveiled it. And now Congress may be getting ready to intervene. A newly proposed bill called … [Read more...]
TECHNOLOGY
10x Genomics Ordered to Pay $23.9 Million for Infringing Bio-Rad’s Patents
January 25, 2019
Case: The Federal District Court jury found that 10x willfully infringed three genetic analysis technology patents that Bio-Rad licensed from the University of Chicago on an exclusive basis. … [Read more...]
LEGISLATION
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
January 14, 2019
By Danielle Sloane bio and Chris Climo bio In a recent piece of federal legislation intended to address the opioid crisis across the United States, Congress enacted a new all-payor kickback … [Read more...]
