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
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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
FDA to Keep COVID-19 EUA Pipeline Open for Now
U.S. Department of Health and Human Services secretary takes action to ensure continued access to COVID-19 EUA products.
Lab Owner Pleads Guilty to $89 Million Fraud Scheme
Last week saw two key lab-related cases, with the biggest involving a fraud scheme relating to cancer genetic testing.
No Surprises Act Independent Dispute Resolution Process Resumes
HHS orders arbitrators to go back to resolving payment disputes between providers and payors under the No Surprises Act.
Medicare to Pay for 22 Additional PLA Codes, Starting April 1
To ensure proper Medicare Part B billing and coding, your billing staff must be aware of all 22 of the newly recognized PLA codes.
The ABN Modifiers and How to Properly Use Them
Proper usage of ABN-related modifiers is a significant issue that has a direct impact on your lab’s reimbursement and compliance.
How Technology Is Solving Key Challenges in the Clinical Lab
Leanne Davey of Waters Corporation discusses recent technological trends in the clinical space with G2 managing editor Rachel Muenz.
Labs in Court: Three Lawsuits Tossed
In this month’s roundup, three cases—including two whistleblower lawsuits and one workplace discrimination case—get dismissed.
What Can Go Wrong with Outsourcing Lab Billing and Coding?
Lab leaders must be able to make a sound assessment of both the costs and benefits, and the liability risks involved.
A Due Diligence Checklist for Vetting Medical Billing Company Compliance
Labs have a duty to inquire into what their billing company is up to and whether it complies with all applicable regulations.
OIG OKs Pharma Company’s Use of Financial Help for Patients
Recent Advisory Opinion sheds light on offering patients financial assistance so they can receive the provider’s products and services.
