LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
FCA Recoveries Decline despite Increase in Enforcement Activity
The DOJ's 2022 Fraud Statistics Overview shows it raked in less than 50 percent of what it recovered in FY 2021.
Illegal Marketing Commissions Arrangements Cost Toxicology Lab $5.9 Million
Recent case shows that toxicology labs and drug testing remain a primary target for federal enforcement agencies.
Senators to HHS: Keep Covering At-Home COVID-19 Tests After PHE Ends
Group of 18 senators says ending Medicare coverage for at-home COVID-19 tests would undo efforts to contain spread of the coronavirus.
Medical Device Executives Nailed with Fraud Charges
The three Magellan Diagnostics executives are accused of FDA violations, as well as wire fraud and conspiracy.
Theranos’ Holmes Won’t Avoid Jail While Her Appeal Is Pending
On Monday, federal Judge Edward Davila denied the disgraced Theranos CEO’s motion to remain free while she appeals her conviction.
Grassley’s Bill Aiming to Amend FCA Passes Senate
The bipartisan bill was recently reintroduced to amend the FCA in response to a landmark 2016 Supreme Court ruling.
Almost Half of Healthcare Workers Burnt Out during Pandemic
A recent study revealed burnout rates of 49.9 percent among healthcare professionals during the early stages of the COVID-19 pandemic.
Lab Institute Virtual Event: Dealing with a Difficult Economy
Our June virtual event will offer a variety of solutions and strategies for dealing with key issues labs face during times of economic strife.
Reintroduction of SALSA Revives Labs’ Hopes for PAMA Relief
New legislation would force CMS to change the way it calculates Medicare prices for lab tests.
FTC Orders Illumina to Unwind Grail Acquisition
On Friday, the US federal trade commission ordered Illumina to divest Grail, which it acquired for $8 billion in August 2021.
