Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
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
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Home-Based Flu Tests as Accurate as Rapid In-Clinic Options
Home-based, self-administered tests for influenza are comparable in accuracy to rapid diagnostic tests in clinical settings, according to a recently published, peer-reviewed study. “Home tests are a valuable tool to support the management of influenza and other...
New Act Would Mean Wider Medicare Coverage of Genetic Cancer Screening
Legislation would require Medicare to cover genomic cancer testing and follow-up screening for those with a family history of cancer.
ONC Seeking Public Input on Electronic Prior Authorization Standards
The ONC requested input on certification standards for the development and implementation of electronic prior authorization IT products.
Website Ad Doesn’t Bar Qui Tam Suit for Rewards Program Fraud
A new case from the US Court of Appeals for the Ninth Circuit tests how far the public disclosure bar goes.
Study Finds Screening Tool for Autism Is World’s Most Accurate
Research has found an early screening tool for autism developed by La Trobe University, Australia, researchers—and already used across eleven countries—is the world's most accurate. Published in JAMA Open, the five-year study of over 13,500 Victorian children found...
Theranos Story Gets the Miniseries Treatment on Hulu
Those who want more of the Theranos story can get their fill now that The Dropout, a miniseries starring Amanda Seyfried as founder Elizabeth Holmes, has launched on streaming service Hulu. Premiering on March 3, the series currently has a 7.4/10 rating on IMDb.com...
