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”
News
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Subscribe today for access to
Articles and Reports
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
President Orders Private Payors to Cover At-Home, Rapid COVID-19 Testing
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
The Top 10 Diagnostics Deals of 2021
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Asking the Wrong Safety Questions
By Dan Scungio...
Who knew vaccine requirements could be so much fun?
By Mike O’Brien...
CMS Repeals Rule Providing Expedited Medicare Coverage for MCIT “Breakthrough” Devices
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
How to keep the safety reaction sharp in the lab
By Dan Scungio...
Becton Dickinson Lands $40.3 Million BARDA Contract to Develop 510(k)-Worthy COVID-19 Tests
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Blue Cross Blue Shield Sues National Lab for COVID-19 Test Price Gouging
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
How to Manage Liability Risks for Pass-Through Billing Arrangements
Pass-through billing arrangements are those in which labs send a test specimen to an outside lab for testing and then bill the patient’s insurer for the test performed. Here’s a look at the potential liability risks and a strategy for managing them.