Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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Latest Articles
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”
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
Court Nixes COVID-19 Lab Test Reimbursement Lawsuit Against Private Payor
Despite Congress’ clear policy on private insurer payment of COVID-19 tests, many labs have been struggling to get reimbursed.
Five Things Labs Need to Know About the 2023 Clinical Lab and Physician Fee Schedule
In case you don’t feel like reading all 3,300+ pages of the Final Rule, here’s a quick briefing on the main changes you should be aware of.
Weekly Enforcement Report: COVID-19-Related Cases Take Center Stage
Though light on lab-related cases, last week’s enforcement actions cracked down on COVID-19-related violations.
CMS Hikes 2023 Medicare OPPS Reimbursement Rate 3.8 Percent
However, the increase still isn’t enough to keep pace with inflation, providers contend.
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.
