Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
Attitude Toward Inpatient Testing Frequency Varies By Provider Type
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Eliminating Creatine Kinase–Myocardial Band Testing Saves Money, Improves Quality
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Future of Traditional Rapid Flu Tests in Doubt as New Review Highlights Improved Performance of New Testing Technologies
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Don’t Crash & Burn: Why Cutting Your Quality Department’s Budget is not a Good Idea
By Jennifer Dawson, MHA, DLM (ASCP) bio
Do you think that you can improve your organization's bottom line by reducing the budget to your quality program and cutting its staff…
Newly Proposed PAMA Rates for 2018 Confirm Lab Industry’s Worst Fears
From - National Intelligence Report
CMS's newly issued preliminary Clinical Laboratory Fee Schedule (CLFS) for 2018 dashes the lab industry's hopes for PAMA relief by making two things…
You Make the Call: Is Replacing Spoiled Products for Free an Anti-Kickback Violation?
From - G2 Compliance Advisor
The following scenario comes right out of an August 25, 2017 OIG Advisory Opinion. See if you can guess how the OIG ruled…
Fanning the Flames
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Memorizing what actions to take in a fire situation is important, and reviewing this topic in October, National Fire Prevention Month, is both timely and…
Beware of Accidental Discrimination in Lab Job Ads
From - G2 Compliance Advisor
Before civil rights laws, job ads like these were seen as perfectly normal. Today, employers aren't allowed to post job ads with phrases that exclude or express preferences based on…
Case of the Month: FMC Settlement Is Poster Child for False Billing of Lab Tests
From - G2 Compliance Advisor
In the grand scheme of things, $2 million is fairly small potatoes for false billing of lab tests—especially considering that it allegedly…
Industry Trends: New Report Sheds Light on DX Tech Capital Flows
From - Laboratory Industry Report
The health care industry has raised $5 billion in venture fund investment in the first half of 2017 and is well on pace to smash the single year record of…