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
Healthcare Staffing Shortages Are Number 1 Issue in Recent Report
While likely not a surprise to medical labs, a new report may add more urgency to solving recruitment and retention issues.
Call for Speakers & Topics — G2 Intelligence Webinars & Events
We’re inviting our readers to share their ideas for topics and presenters, both for future standalone webinars and our virtual events.
CMS Publishes Final Clinical Laboratory Fee Schedule for 2023
The Final Rule caps future PAMA cuts at 15 percent per calendar year.
Feds Target Directly Billing Medicare for Tests Furnished by Reference Labs
A California health system will pony up $13 million to settle reference lab billing fraud claims.
FDA Revises EUAs for COVID-19 Antigen Tests
In response to the latest data on repeat testing, on Nov. 1, the agency made a few changes to EUAs for such tests.
Lab Tests the Theme in Recent Enforcement Actions
A doctor settles alleged FCA violations involving genetic tests, while a clinical lab owner pleads guilty for his role in another scheme.
Rise in Telehealth Expands Need for In-Home Phlebotomy Services
Mobile phlebotomist services have become a dynamic new segment of the medical labs market.
Lab Institute Who’s Who: Danielle Tangorre
Learn about the current state of the No Surprises Act, challenges in compliance, and how to navigate the law.
ACLA: Low Reimbursement Jeopardizes Monkeypox Lab Testing Effort
Medicare Administrative Contractors are shortchanging labs on monkeypox test reimbursement, association says.
Sutter Health Pays Millions to Settle Improper Billing Claims
The healthcare services provider will be on the hook for $13 million for alleged improper billing of lab tests.
